Protocol Tracking Reports: Dashboard
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| Breast Cancer | ||
| S2428 Randomized Phase III trials of multimodality therapy versus palliative therapy in triple-negative (TNBC) and HER2 positive (HER2+) de novo (AJCC stage IV) oligometastatic breast cancer. |
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Capsule Summary Approval Date: 02/12/2024
Concept or Lol submit to NCI: 03/19/2024 Target Date: 02/15/2025 Drop Dead Date: 11/12/2025
Progress:
66
of 270 days
Current Status: 06/14/24: Study Team received BCSC review outcome and the outcome is still pending. Study Team will proceed to address the review comments and update the concept for re-submission. CTEP/SWOG call to discuss the comments was had on Tuesday, 06/18/24. 06/04/24: The concept was reviewed by the BCSC on 05/21/24 and the Study Team is awaiting the outcome of the review. 05/07/24: F/F call completed 04/15/24. Concept submitted and BCSC review scheduled for 05/21/24. 03/05/24: Triage approved on 02/12/24. In the process of scheduling the F/F call. Aiming for 04/16/24 BCSC Review. 05/21/2024: BCSC review. 06/05/2024: Review on hold with major comments received. 06/18/2024: NCI call for review on hold. 06/25/2024: Re-submitted for BCSC review. 07/16/2024: BCSC Re-review. |
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| Cancer Care Delivery | ||
| S2417CD A Pragmatic Randomized Controlled Trial to Evaluate the Effectiveness of an Intervention to Promote Guideline-Concordant Colorectal Cancer Surveillance |
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Capsule Summary Approval Date:
Current Status: 7/2/24: Sending out poll to schedule study team call and F&F call. Date for Rapid is pending. 7/1/24: Awaiting stat input of Sections 6, 10 and 11 of protocol. 6/11/24: Study chairs updated protocol template. Shared with study team. 5/31/24: Kate Castro hosted "Planning for R01 using NCORP Network" call. Protocol development timeline sent to study team. Protocol template sent to study chairs. 5/24/24: Feedback from PRO Core Team provided. 5/14/24: PRO measures table and CanCORS survivor survey was reviewed by the PROCore Team. 5/6/24: As this study scored in the 6th percentile, it will likely be funded. Kate Castro confirmed that Notice of Award would likely be sent in July 2024. PROs will be reviewed by PROCore Team later this month. Had "Next Steps" call with study team. Sent examples of SWOG protocols to Study Chairs. We will work off of the assumption that the protocol will be submitted in October 2024. F&F call and Rapid call to be scheduled soon to get dates secured on the calendar. 2/22/24: Per Dr. Vennstra, application is scheduled for study section on March 21, 2024. 10/5/23: Per Dr. Veenstra, the R01 was submitted. |
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| S2424CD Randomized Controlled Trial of a Lay Health Worker-led Intervention to Promote Goals of Care Communication |
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Capsule Summary Approval Date:
Current Status: 6/28/24: Dr. Parikh received notification that the R01 scored in the 4th percentile therefore likely will be funded. We will await the funding decision but need to get started on next steps planning. 2/5/24: R01 submitted. Approved by Triage 1/22/24. 11/14/23: PRO measures reviewed by PROCore Team. Recommendations distributed to study chairs on 11/15/23. |
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| Cancer Survivorship | ||
| S2423 Testing the Fatigue Reduction Diet in People with Early Stage Breast Cancer: A Randomized Controlled Trial, The GUIDE Study |
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Capsule Summary Approval Date: 01/22/2024
Current Status: Study introduction call w/ Pat Mize occurred 11/6/23 PRC occurred 12/21/23 and comments were sent back to the study team PRO Core team will reviewed 1/9/24 .Comments back to team 1/12/24 New DCP leadership reviewed docs on 1/12 and approved to move forward Pat Mize confirmed that a mini F&F was not needed. Triage reviewed informally on 1/22/24. Aiming for early Feb R01 submission. R01 submitted early Feb. R01 being reviewed 6/6-6/7. Study team plans to resubmit in November 2024 depending on summary statements from review. Scored 38, 36th percentile |
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| S2435 Phase III Trial of an App-delivered Sleep Coaching Intervention in Post-Treatment Survivors of Diverse Cancers and their Bedroom Partners |
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Capsule Summary Approval Date:
Current Status: **R01 SUBMISSION for June 2024** PRC review 5/8. PRO Core team reviewed 5/14. Triage informally approved on 5/13. Pat Mize determined no need for mini F&F. R01 submitted June 5th. Response expected Q4 of 2024. |
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| comboMATCH | ||
| EAY191-S6 CAMELOT Phase II Basket Trial: ATR inhibitor Camonsertib and PKMYT1 inhibitor Lunresertib combination in advanced solid tumors with CCNE1 amplification or deleterious alterations in FBXW7 or PPP2R1A |
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Capsule Summary Approval Date:
Current Status: 07/01/2024- Concept was submitted to CTEP 6/13/24. 06/01/2024- Study Team is finalizing concept for CTEP Submission 3/11/2024- Steering Commitee Approval. |
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| Early Therapeutics & Rare Cancers | ||
| S2310 Phase II/ III Randomized Study Testing Non-Inferiority of Shorter-Course Radiation Versus Standard Fractionation for High-Risk, Resectable Sarcoma |
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Capsule Summary Approval Date: 01/29/2024
Concept or Lol submit to NCI: 03/29/2024 Target Date: 02/23/2025 Drop Dead Date: 11/20/2025
Progress:
58
of 270 days
Current Status: 5/29/24 - CTEP internal review of concept 3/29/24 - Concept submitted to CTEP. 3/4/24: F &F call held, planning to submit concept on or before 4/1/2024. 2/5/24: F & F call is pending scheduling; meeting poll is being circulated. 1/29/24: Triage approved the capsule. 1/8/24: Triage reviewed updated capsule and study chairs triage response letter internal on 1/8/24 triage meeting. Executive Officers decided they want study chair to join upcoming triage meeting to discuss new study design, conversations SC had with the interested institutions and NCI. Tentatively scheduled for 1/29/24 triage meeting. 6/6/23: Dr. Harris is reviewing survey results and preparing a response letter for Dr. Ryan. 4/14/23: proposal received an approval on hold pending a response to the outcome of a survey. Committee is concerned about the feasibility to conduct this study. The Committee requests the study team to survey institutions (large institutions and community sites) to determine if there is an equipoise and interest in registering participants to the study. 1/8/24 - Triage approval. The study was redesigned based on the previous triage comments and discussions with sites and the NCI. The triage comments were addressed. |
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| S2425 A Randomized Phase II Study of Temozolomide in Combination with Atezolizumab (Tem-Atezo) versus Temozolomide Alone in Adults with Advanced Bronchopulmonary Neuroendocrine Tumors. |
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Capsule Summary Approval Date: 01/29/2024
Current Status: 07/02/24: The study team continue to address post-F&F action items and will present the draft concept to the GI NET Subcommittee on 07/11. 06/04/24: The study team is addressing the post-F&F action items, including the following: (1) Streck tube funding discussion with Genentech (2) Gauging PRO interest/feasibility with the NCI (3) Concept review by NGI NET Subcommittee 05/07/24: Risk Assessment was held on April 30th and the F&F Review will take place this Friday, May 10th. 02/06/24: The Capsule has been approved by Triage. |
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| S2429 A phase Ib/II study of encorafenib, binimetinib & regorafenib in advanced or metastatic BRAF V600E mutated solid tumors that have progressed on prior RAF +/- MEK inhibition |
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Capsule Summary Approval Date:
Current Status: 06/04/24: Pending/planning collaborator (Bayer, Pfizer, Guardant) Kick-Off calls before moving forward with F/F call and aiming for F/F call in the upcoming months. 05/04/2024: Pending/planning collaborator (Bayer, Pfizer, Guardant) Kick-Off calls before moving forward with F/F call. Aiming for June F/F call. 2/22/2024: Triage approved capsule. |
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| S2432 DART II: Dual Anti-LAG-3 and Anti-PD-1 Blockade in Rare Tumors |
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Capsule Summary Approval Date:
Current Status: 07/02/24: The F&F Meeting has been rescheduled for 07/30/24 and a separate meeting with BMS is being scheduled to discuss recent updates. Outstanding questions still remain with the Concept and SAW which require SC input. 06/04/24: Currently focused on rescheduling the F&F meeting following the late cancelation last month due to unforeseen scheduling conflicts. Require SC input on the SAW (specific to TM components) and outstanding Concept questions. Lastly, we are also in the process of determining the status of the BMS CRADAs related to Relatlimab. |
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| SN2426 A Randomized Phase II Study of Amivantamab versus Cetuximab in Immunocompromised Patients with Recurrent Inoperable or Metastatic Cutaneous Squamous Cell Carcinoma |
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Capsule Summary Approval Date: 02/08/2024
Concept or Lol submit to NCI: 06/27/2024 Target Date: 11/23/2024 Drop Dead Date: 08/20/2025
Progress:
10
of 130 days
Current Status: 2/8/24: Triage approved capsule. F & F call- Tentatively scheduled for 3/13/24 5/16/2024: concept submitted for CTEP review 7/16/2024: CTEP concept review received 7/17/2024: teleconference with study team to discuss response. Goal to have response and updated concept within one week |
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| Gastrointestinal Cancer | ||
| S2433 A Randomized Phase II Trial of Panitumumab with Second-Line Chemotherapy or Chemotherapy Alone for Locally Advanced or Metastatic KRAS/BRAF V600E Wild Type Pancreatic Adenocarcinoma |
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Capsule Summary Approval Date: 04/01/2024
Current Status: 11/1 - Preliminary meeting with Amgen 4/1 - Approved by SWOG Executive Committee and awarded # S2433. 5/3 - Study Team Kick off meeting 6/10 - Submitted concept to GISC 6/14 - F&F Call 6/14- Received PRO Core feedback. 6/26 - KOC with Amgen 7/15- Review by GISC |
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| Genitourinary Cancer | ||
| S2312 A Phase III Study of Cabazitaxel with or without Carboplatin in Patients with metastatic castrate-resistant prostate cancer (mCRPC), Stratified by Aggressive Variant Signature |
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Capsule Summary Approval Date: 04/19/2023
Concept or Lol submit to NCI: 05/24/2023 Target Date: 03/17/2024 Drop Dead Date: 12/12/2024
Progress:
401
of 270 days
Current Status: **Planned Activation Date: 08/01/2024** **Drop Dead Date: 12/12/2024** Triage approved capsule and TM proposal 4/19/23. F&F call held on 5/1. Aiming for 5/24 GUSC submission deadline for their 6/21 review. BIQ application will also be submitted for integral TM to GUSC. Concept and BIQ docs submitted to GUSC for 6/21 review. Concept and BIQ reviewed on 6/21 by GUSC. Pending response from GUSC. Response from GUSC received 7/7 (Decision: Pending). Dr. Corn will respond to comments and submit by 8/2 for the 8/16 review date. Response submitted to 2nd round of comments from GUSC on 8/18 for 9/20 review. Concept re-reviewed by GUSC on 9/20. Currently waiting on response from GUSC and drafting protocol. Plan to poll for RaPID times before Group Meeting. GUSC approved concept on 10/13. 1st protocol draft sent to team before RaPID meeting planned for 12/4. Still waiting on GUSC decision for BIQ funding. GUSC approved BIQ funding on 11/17. RaPID call occurred 12/4. Plan to hold TM F&F call. TM F&F call occurred 12/20. Stats PRC will be scheduled after Dr. Corn returns from leave on 1/16. PRC occurred on 1/31. Aiming for first CTEP submission end of February. Submitted to CTEP for initial review on 2/29. Currently drafting additional DCT language for consensus review. Consensus review comments received on 3/26. Responses to consensus review sent to NCI on 4/26 along with updated DCT language. CIRB review for Initial Review App scheduled for 6/6/24. Addressing dry run concerns with TM chairs as well (planned dry run for week of 6/17) Responses to IR app comments submitted to CIRB on 6/26. MTA from Dr. Goldkorn's institution sent to MD Anderson for dry run. MD Anderson team reviewing Dr. Lerner's request to forego the need for CIRB approved protocol/consent for the dry run as of 7/1. |
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| S2419 Phase II/III Double Blinded Trial of Immune-Based Therapy with a Live Biotherapeutic CBM588, or Placebo for Frontline Therapy of Advanced Clear Cell Renal Cell Carcinoma (BioFront Trial) |
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Capsule Summary Approval Date: 11/27/2023
Current Status: 11/27/23: Concept approved by triage. Currently scheduling risk assessment and F&F calls. Plan to schedule kickoff call with Osel (pharma co) after F&F call is complete. Risk assessment occurred 12/8. F&F occurred 12/18. Plan to submit to GUSC by 7/26 for the September review date. Scheduling kickoff call with Osel before then (CBM588, SWOG-held IND, placebo controlled live bacteria) Following up on action items from kickoff call with Osel (6/17), and plan to send draft budget for registration trial for their review. Plan to submit to GUSC by 7/26 for the September review date. |
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| S2427 Bladder preservation with immunoradiotherapy after a clinically meaningful response to neoadjuvant chemotherapy in patients with muscle invasive bladder cancer (BRIGHT) |
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Capsule Summary Approval Date: 02/05/2024
Current Status: Triage approved 2/5/2024. Risk assessment occurred 3/22. F&F call occurred 4/22. Study team updating concept. IROC RI reviewing concept and Merck support confirmed (CTEP-held IND). 5/29 submission to GUSC for 6/26 review date. Concept submitted to GUSC for 6/26 review date. Placeholder on calendar for internal discussion about steering committee questions and run through of slides for GUSC on 6/25. GUSC reviewed concept on 6/26. Pending response. |
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| Leukemia | ||
| S2421 A Randomized Phase II Study of Pirtobrutinib plus R-CHOP vs. R-CHOP for Patients with Previously Untreated Richter Transformation (RT) |
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Capsule Summary Approval Date: 01/08/2024
Concept or Lol submit to NCI: 05/16/2024 Target Date: 12/11/2024 Drop Dead Date: 09/07/2025
Progress:
42
of 180 days
Current Status: NCI Teleconference: 7/29. Major comments received from LYSC on 7/10/24. Will need to revise and resubmit for August or September LYSC meeting. 06/14/2024: LYSC review. 06/03/2024: Verified that concept will remain under the Leukemia Committee at SWOG but will be reviewed by the LYSC. 05/06/2024: Notified of 6/14 LYSC review, reached out to clarify that it should be LKSC, pending response. 04/29/2024: Submitted to LKSC 04/24/2024: Kick-off call with Eli Lilly 03/26/2024: F&F call. 03/12/2024: PROCore Review & recommendations submitted. 03/05/2024: PRO proposal submitted for March review. 03/05/2024: Risk Assessment. 02/09/2024: Internal Study Team Meeting. 01/22/2024: Triage approval letter received. |
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| S2434 A Phase 1B Study Assessing the Safety and Activity of SNDX-5613 (revumenib) in Combination with Age-Modified Chemotherapy in Newly Diagnosed Patients with KMT2Ar Acute Lymphoblastic Leukemia (ALL) or Acute Leukemia with Ambiguous Lineage (ALAL) |
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Capsule Summary Approval Date: 04/22/2024
Current Status: 02/07/2023: Capsule approved by Triage. 02/28/2023: Risk assessment completed. 03/06/2023: F&F occurred. 03/28/2023: LKSC submission pending further study edits, COG review, and ALL working group meeting. 07/17/2023: TM capsule triage review. 07/26/2023: TM capsule triage approved. 07/31/2023: Study chairs working funding for TM and COG is reviewing capsules. 8/29/2023: LKSC submission. 09/21/2023: CTEP PRC occurred, awaiting consensus review. 10/16/2023: NCI OEWG call scheduled. 10/16/2023: NCI OEWG call cancelled, pending rescheduled date. 10/23/2023: NCI OEWG call occurred, LKSC submission withdrawn. 01/04/2024: Re-design sent COG for formal Scientific Council and Developmental Therapeutics Committee review. Also sent to EO for determination of need for Triage re-review. 01/25/2024: COG Scientific Council Review received, still pending Developmental Therapeutics Committee Review. 02/22/2024: COG Developmental Therapeutics Committee Review received. Study team is working through edits and responses. 02/29/2024: Awaiting triage submission approvals. 04/22/2024: Undergoing triage review. 04/22/2024: Assigned new study number of S2434. 05/02/2024: Pending internal study team kick-off call. 05/22/2024: Internal study team kick-off call. 07/01/2024: Pharma Kick-Off call with Syndax scheduled. 07/22/2024: Pharma Kick-Off call with Amgen scheduled. 07/29/2024: F&F Call Scheduled. |
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| Lung Cancer | ||
| S2313 Neoadjuvant Chemo-Cemiplimab for Clinical Stage I, 2-3.9cm, Non-Small Cell Lung Cancer: A Randomized Controlled Trial |
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Capsule Summary Approval Date: 05/04/2023
Current Status: 7/18/24: TMSC Review 6/6/24: TMSC Concept Submission 5/31/24: Concept has been updated and reviewed by stats and SWOG ops. 5/7/24: Verbal commitment from Regeneron for cemiplimab and all chemo agents received on 5/3/24. Next steps include updating the concept with the new agents and obtaining Regeneron's full review and sign-off. 3/6/24: The study team is continuing discussions with potential collaborators, including Genentech and Regeneron, for funding support. 2/6/24: The study team is refining the concept and developing budget estimates after the 1/10/24 teleconference with Merck. A follow-up call with Merck is scheduled for 2/7/24 to discuss study redesign details, including a potential single-arm, phase II trial with pCR as the primary endpoint. Meetings with Genentech and Regeneron for funding support are also being considered. 1/9/23: AstraZeneca will not support the concept due to a shift in their priorities for stage I NSCLC. The study chairs are now pursuing discussions with other pharma partners, including Merck, for funding of neoadjuvant chemo agents and biomarker tests. The concept will undergo revisions and is aimed for submission to CTEP in Q1 2024. 12/5/23: The study team is addressing concept revisions and TM logistical aspects, including pCR tissue processing and ctDNA analysis. Submission to CTEP TMSC is anticipated by 12/14/24, with the understanding that AstraZeneca will fund the neoadjuvant chemo agents and biomarker tests. 11/7/23: The study team is addressing concept revisions and TM logistical aspects, including pCR tissue processing and ctDNA analysis. Despite a second F&F meeting on 11/3/24, many details remain unresolved. The team is awaiting a response from AstraZeneca regarding funding for neoadjuvant chemo agents and biomarker tests. TMSC submission is delayed until December to ensure complete TM logistical components before starting the OEWG timeline. 10/3/23: The study team is addressing concept revisions and outstanding questions regarding study design, patient eligibility, specimen flow, and funding. TMSC submission is postponed until these are resolved. A risk assessment call was held on 9/29, and the F&F meeting is scheduled for 10/6/24, with an additional meeting possible if needed. 9/5/23: The study team is reviewing the revised concept and preparing for further discussions on the BIQSFP, anticipating TMSC concept submission in mid-October. 8/1/23: The study team is working on the LOI for redesign and the BIQSFP submission. 5/4/23: Exec. Committee/Triage approved. TMSC has confirmed they will review the concept on 7/18/24. Consequently, the OEWG start date will also be 7/18/24, giving us until 10/11/25 to meet the OEWG absolute deadline for activation. |
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| S2409 PRISM: PRecIsion in SCLC via a Multicohort Study: Randomized Phase II studies evaluating maintenance Durvalumab with or without Biomarker-Directed Therapy for Extensive Stage Small Cell Lung Cancer (ES-SCLC) |
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Capsule Summary Approval Date: 07/12/2023
Target Date: 06/11/2024 Drop Dead Date: 03/08/2025
Progress:
225
of 180 days
Current Status: 7/10/24: Stats PRC Review 6/10/24:RaPID #2 5/22/24: RaPID #1 4/12/24: AZ provided a letter of support 2/22/24: AZ global review 2/22/24: BIQSFP Disapproval 12/14/23: TMSC Approval 10/30/23: F&F Call 9/21/23: TMSC concept/ BIQSFP submission deadline for October TMSC review date 7/12/23: Exec. Committee/Triage approved Absolute Deadline: 03/08/2025 |
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| S2410 A randomized phase II study of a PDL1 inhibitor and iadademstat (ORY-1001) versus investigators choice of standard of care for second line treatment of extensive stage small cell lung cancer (SCLC) |
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Capsule Summary Approval Date: 07/24/2023
Target Date: 05/14/2024 Drop Dead Date: 02/08/2025
Progress:
253
of 180 days
Current Status: 5/23/24: Introductory Call with Jubilant 2/27/24: TMSC Disapproval due to iadademstat unable to be provided for this study 2/12/24: RaPID Call 12/14/23: Approval on Hold; Pending Oryzon drug commitment 11/16/23: TMSC Review 9/18/23: F&F Call 7/24/23: Exec. Committee/Triage approved The study team met with Jubilant on 5/23 to discuss the differences between a SWOG-held IND and a CTEP-held IND, as well as the CRADA process. Anna is preparing a budget to send to Jubilant for their consideration as we decide whether to pursue the SWOG-held IND route. |
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| S2414 INcorporating pathologic reSponse in patIents with early staGe lung cancer to optimize immunotHerapy in the adjuvanT setting (INSIGHT) |
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Capsule Summary Approval Date: 08/21/2023
Concept or Lol submit to NCI: 08/24/2023 Target Date: 06/17/2024 Drop Dead Date: 03/14/2025
Progress:
309
of 270 days
Current Status: 04/25/24: Received CTEP Consensus Review 03/28/24: CTEP initial protocol submission 02/21/24: Stats PRC; Comments are being incorporated 02/09/24: Call with Nationwide on the TM proposal logistics and budgeting 02/06/24: Rapid is scheduled 01/09/24: Discussion with CTEP/AZ on stats design 11/10/23: Second F&F Call scheduled 11/05/23: First draft of the protocol circulated 10/27/23: First F&F call conducted 10/13/23: Received Concept Approval 10/03/23: Pending TSMC review 09/05/23: Concept is scheduled for a 9/21/23 TMSC Review 08/21/23: SWOG Triage Approved |
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| LungMAP | ||
| S1800E A Randomized Phase II/III Study of Docetaxel and Ramucirumab with or without Cemiplimab for Participants Previously Treated with Immunotherapy for Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Non-Matched Sub-Study) |
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Capsule Summary Approval Date: 04/01/2022
Concept or Lol submit to NCI: 09/21/2023 Target Date: 08/12/2024 Drop Dead Date: 11/16/2023
Progress:
253
of 270 days
Current Status: OEWG start date: 11/16/23 Drop Dead date: 5/9/25 7/26/24 - Initial CIRB submission made.The CIRB Initial Review date is 8/15/24. Anticipating CIRB review comments in late August. Activation is targeted for 11/1/24. 7/26/24 - Received CTEP Approval On Hold 7/17/24 - Submitted S1800E to the FDA 7/15/24 - Submitted Follow-up Review response to CTEP. 7/10/24 - Received CTEP Follow-up Review comments 7/8/24 - Regeneron sent updated Briefing Book to SWOG for a final check. Briefing Book finalized by Lung-MAP and Regeneron teams. 6/26/24 - Submitted CTEP Consensus Review response. CTEP Approval On Hold and CIRB submission anticipated in July. Target FDA submission of the Briefing Book, formal meeting request, and protocol 7/9/24. 5/31/24 - Regeneron submitted the Letter of Authorization (LOA) to cemiplimab IND 123950 in support of S1800E. SWOG received the S1800E LOA from Regeneron. 5/30/24 - CTEP comments resolved. Updated protocol and draft Consensus Review response sent to Regeneron for review. Regeneron's comments are due 6/14/24. Anticipating formal response to CTEP in June. 5/23/24 - Received CTEP Consensus Review comments 5/16/24 - CTEP Consensus Review 4/25/24 - Initial protocol submission to CTEP 4/22/24 - Post-Stats PRC comments received from Regeneron 4/18/24 - SWOG and Regeneron met for their third planning call to prepare for the FDA formal meeting that is anticipated in mid-June. 4/11/24 - Updated post-Stats PRC protocol sent to Regeneron. Regeneron will need about 10 business days to review and provide comments. Initial protocol submission to CTEP anticipated in April. 4/9/24 - Stats PRC comments received from SDMC. 4/2/24 - Once Ops receives SDMC's Stats PRC edits, the protocol and consent will be updated and sent to Regeneron for review. Initial protocol submission to CTEP anticipated in April. 3/27/24 - Stats PRC 3/13/24 - RAPID 3/1/24 - Regeneron provided comments for the first protocol draft. 2/26/24 - Received CTEP Full Approval of Concept 2/20/24 - Regeneron signed and submitted the Drug Commitment Letter to CTEP. 2/15/24 - Updated first protocol draft sent to Regeneron for review. Their edits/comments are due 3/1/24. 2/6/24 - Study team comments for first protocol draft are being incorporated into the second draft. RAPID anticipated in March. The Regeneron legal team is of the understanding that NCI told Regeneron that execution of the CTPA would constitute the drug commitment and the Drug Commitment Letter as a stand-alone document for S1800E is not necessary. However, the signed Drug Commitment Letter is due to CTEP by 4/8/24. FNIH and the SWOG legal team are working to rectify the disconnect about what is required and when. 1/25/24 - First protocol draft sent to the study team for review. Edits/comments are due 2/1/24. 1/8/24 - The revised concept received Approval On Hold on 1/8/24. Full Approval of the concept is contingent upon CTEP's receipt of Regeneron's Drug Commitment Letter for cemiplimab. 12/5/23 - Regeneron is reviewing the revised phase II/III design and will provide their feedback to the Lung-MAP team in the coming week. If Regeneron approves this design, a revised official Concept will be submitted to CTEP in December. S1800E has not yet been added to the OEWG timeline. 11/27/23 - Call with Regeneron to review CTEP feedback and phase II/III design. 11/24/23 - Revised concept with phase II/III design sent to Regeneron. 11/21/23 - Received CTEP comments. CTEP stated they would not approve a straight phase III study without phase I and phase II data. CTEP suggested the study team modify the design to be a phase II/III. 11/16/23 - CTEP review of S1800E Concept and supplemental Study Design and Interim Analysis Plan. 11/15/23 - Study team submitted a S1800E Study Design and Interim Analysis Plan for CTEP review. This document supplements the S1800E Concept. 11/7/23 - Official Concept remains with CTEP. According to PIO, Phase III designs must be reviewed by TSMC. This does not align with the standard review procedure for Lung-MAP concepts. Ops has followed up with PIO/CTEP on a weekly basis to request the review date. After 4 weeks, a date still has not been identified. 10/30/23 - Feasibility & Finance Meeting 10/5/23 - Risk Assessment Call 10/3/23 - Scheduling Feasibility & Finance Meeting 9/21/23 - Official Concept with Phase III design submitted to CTEP 9/5/23 - SWOG Leadership has reviewed and approved the revised concept. The study team will meet with Regeneron on 9/18/23 to discuss Regeneron's review comments. Once Regeneron provides their approval the concept will be submitted to CTEP. 8/7/23 - The study team and Regeneron have agreed to move forward with a Phase III design. The concept is being updated in preparation for CTEP submission. 8/1/23 - The study team will meet with Regeneron again on 8/7/23 to continue discussing the statistical design. 7/11/23 - The study team had a call with Regeneron on 7/6/23. Their leadership team is supportive of the concept, but want to go back to assessing for primary endpoint in all-comers irrespective of PD-L1 status. They are still going back and forth on statistical issues (They want to increase the hazard ratio to 0.65 instead of 0.63 and sample size will probably need to go up to around 380). There is a follow up call on 7/17/23. 6/6/23 - Study team is meeting with Regeneron on 6/7/23 to discuss the study's updated statistical design. 5/2/23 - Study team met with Regeneron 5/1/23. Regeneron confirmed they will not support the study unless it is a Phase II/II and has the primary analyses population of PD-L1 >1%. The study team agreed to wait until Regeneron provides their internal review and approval of the Concept (planned for the end of May) before reaching out to CTEP again. 4/4/23 - Study has changed from a Phase II to a Phase II/III. Regeneron is interested in registrational intent. Last study call held 4/3/23. Regeneron is reviewing the concept and will have comments in the next 1-2 weeks. Study team is looking into eligibility updates. 3/6/23 - Call with CTEP scheduled for 03/09/23 to review pre-look comments. Still pending updates/edits from Regeneron on Concept. Study call scheduled for 03/09/23. 2/15/23 - Pre-look comments received from CTEP 2/7/23 - Revised Concept pending company review with feedback expected later this month. Revised Concept was submitted to CTEP for a second pre-look on 1/26/23. The study team will address CTEP's initial comments in conjunction with comments received from the company review and update the Concept in preparation for an initial submission. 1/26/23 - Revised Concept submitted to CTEP for pre-look 1/9/23 - Concept has been updated to include a stand-alone randomized Phase II design, and it has been sent to Regeneron for review. 9/8/22 - CTEP has put the pre-look on hold due to accrual concerns with Pragmatica. 7/22/22 - Concept Submitted to CTEP for pre-look 5/5/22 - Company KOC 4/1/22 - DSC approved |
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| S1900J A Phase II Study of Amivantamab-vmjw in Participants Previously Treated with High MET-Amplification for Stage IV or Recurrent Non-Small-Cell Lung Cancer (Lung-MAP Sub-Study) |
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Capsule Summary Approval Date: 08/29/2022
Concept or Lol submit to NCI: 02/01/2023 Target Date: 08/15/2023 Drop Dead Date: 09/27/2024
Progress:
526
of 180 days
Current Status: Target activation: Original OEWG Drop Dead 5/11/24, second OEWG Drop Dead 7/26/24, current OEWG Drop Dead 9/27/24 7/25/24 - CTEP Follow-Up Review comments received 7/19/24 - Contract with Janssen fully executed 7/18/24 - Pre-activation revision to update drug formulation from IV to subcutaneous submitted to CTEP 7/8/24 - CTEP granted S1900J a second OEWG extension. The Drop Dead Date is 9/27/24. 7/2/24 - S1900J study team and Janssen have updated the protocol to include subcutaneous amivantamab. Ops is working to complete the pre-activation revision as soon as possible. 6/28/24 - Janssen sent the updated contract to SWOG/FNIH. The S1900J study team is working to revise the protocol to include subcutaneous amivantamab. 6/20/24 - Janssen has notified SWOG that due to new findings on Janssen's PALOMA-3 study, the company is requesting to use subcutaneous amivantamab as opposed to IV for S1900J. Janssen’s legal team prefers to make the necessary changes to the current agreement to reflect subcutaneous amivantamab rather than sign it as-is with IV amivantamab. Therefore, Janssen would like SWOG to update the protocol, ICF, and contract before the study activates. The current IB and IPPI may not have enough data to support the protocol revision. SWOG has requested a second OEWG extension (the Drop Dead Date is 7/26/2024). Decision anticipated the second week of July. 6/4/24 - Updated contract execution/activation timeline was shared with Janssen in late May. Anticipating activation in mid-July. Janssen returned what should be the final draft of the CTPA yesterday afternoon. FNIH has shared this version with the Cooley law firm to review and confirm it is consistent with SWOG/NF's position from the prior version of the agreement. SWOG and FNIH are working with Janssen to address the signature routing process. 5/13/24 - CTEP has determined that an OEWG extension is required for S1900J to continue. The new OEWG deadline is 7/26/24. 5/3/24 - OEWG timeline extension request reviewed by CTEP. Pending CTEP's decision regarding an absolute deadline. 4/16/24 - Ops submitted an OEWG extension to CTEP. The request will officially be reviewed on 5/3/24. After the CTEP OEWG Committee meets on 5/3/24, they will provide SWOG with an absolute deadline. 4/2/24 - Janssen contract execution anticipated in early April. 3/5/24 - Janssen contract execution anticipated in March. 2/6/24 - Janssen contract execution anticipated in the coming month. 1/9/24 - Janssen contract execution anticipated in the coming month. 12/5/23 - Target contract execution in late December 2023 or early Q1 2024. 10/27/23 - Received CIRB Final Approval of Initial Review 10/17/23 - Responded to CIRB Initial Review comments 10/12/23 - CIRB Initial Review comments received 10/5/23 - CIRB Initial Review 9/20/23 - Minor FDA recommendations received (no clinical hold) 9/8/23 - Received CTEP AOH and Submitted to CIRB 9/6/23 - S1900J Submitted to the FDA 8/25/23 - Responded to CTEP Follow-Up Review comments 8/18/23 - CTEP Follow-Up Review comments received 8/3/23 - Responded to CTEP Consensus Review Comments 7/11/23 - CTEP Consensus Review comments received 6/29/23 - CTEP Consensus Review of protocol 6/2/23 - Initial protocol submission to CTEP 5/15/23 - Janssen review comments received 5/3/23 - Stats PRC of protocol 4/25/23 - Received CTEP Full Approval of concept 4/7/23 - RaPID 3/28/23 - Response to CTEP concept Consensus Review comments submitted 3/2/23 - CTEP concept Consensus Review comments received 3/2/23 - Feasibility & Finance Call 2/9/23 - Risk Assessment 2/16/23 - CTEP PRC of concept 2/10/23 - First draft of protocol sent to the study team 2/1/23 - Official concept submitted to CTEP 1/18/23 - Stats PRC of concept 1/5/23 - NCI call to discuss pre-look comments 12/6/22 - Study team is finalizing responses to CTEP pre-look comments 11/29/22 - Pre-look comments received from CTEP 10/26/22 - Concept pre-look submitted 10/13/22 - Company Kick Off Call 10/11/22 - Internal Kick Off Call 10/3/22 - Study team is working on study design/ concept 8/29/22 - DSC Approved |
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| S1900M A Phase II Study of Trastuzumab Deruxtecan (T-DXd) in HER2 Wild-Type, HER2 (ERBB2) Amplified Relapsed/Refractory Advanced Non-Small-Cell Lung Cancer (Lung-MAP Sub-Study) |
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|
Capsule Summary Approval Date: 12/04/2023
Current Status: 7/22/24 - Daiichi Sankyo notified the Lung-MAP team of their decision to table S1900M primarily due to budget constraints. 7/2/24 - Lung-MAP/FNIH/SWOG met with Daiichi Sankyo on 6/14/24 to discuss the budget. Daiichi Sankyo is discussing the budget internally with their global team. The timing of the CTEP pre-look submission is dependent on the outcome of Daiichi Sankyo's decision. 6/4/24 - Daiichi Sankyo's decision regarding the concept is pending. The budget was the biggest issue. Daiichi Sankyo is setting up an internal meeting with their global team to push them to make a decision. The timing of the CTEP pre-look submission is dependent on the outcome of Daiichi Sankyo's review. 5/14/24 - Daiichi Sankyo Review Committee will formally discuss the study team's responses and reach a decision regarding the concept on 5/23/24. The timing of the CTEP pre-look submission is dependent on the outcome of Daiichi Sankyo's review. 5/7/24 - The study team is awaiting a final decision from Daiichi Sankyo regarding their review of the concept. 4/26/24 - Study team responded to Daiichi Sankyo's follow-up questions. 4/19/24 - Follow-up questions received from Daiichi Sankyo 4/18/24 - Daiichi Sankyo concept review 4/2/24 - Daiichi Sankyo will review the concept on 4/18/24. The Lung-MAP team expects to receive feedback from Daiichi Sankyo in late April or early May. Anticipating CTEP pre-look submission in May. 3/7/24 - Concept submitted to Daiichi Sankyo for review via their portal. 3/5/24 - Concept has been entered into Daiichi Sankyo portal. Submission is pending entry of the draft budget. This will be added this week. Anticipating CTEP pre-look submission in late March. 2/27/24 - Concept reviewed and approved by Lung and Lung-MAP Leadership. 2/22/24 - Daiichi has explained that for legal reasons we must submit the Concept to them via their portal. Therefore, to move development forward, SWOG leadership has determined that they will allow the Network Operations Center to submit the S1900M Concept accordingly. 2/9/24 - Internal Kick Off Call 2/5/24 - Study team met to discuss the study design and work on the concept form. Anticipated completion of the concept form 2/16/24. Concept will be reviewed by Daiichi Sankyo prior to CTEP pre-look submission. 1/26/24 - Administrative Kick Off Call 1/9/24 - Study team is working on the concept. Internal Kick Off Call 2/9/24. FNIH is planning the Administrative and Scientific Kick Off Calls. 12/22/23 - Drs. Saltos and Doroshow accepted the invitations to serve as Study Chair/Co-Chair. Dr. Edelman accepted the invitation to serve as Champion. 12/18/23 - Study Chair Welcome Letters sent 12/15/23 - Daiichi Sankyo agrees to support the study. 12/4/23 - DSC Approved |
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| S1900N A Phase II Study of Sacituzumab Govitecan and Ivonescimab in Participants with Relapsed/Refractory Advanced Non-Small-Cell Lung Cancer with Actionable Genomic Alteration (Lung-MAP Sub-Study) |
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|
Capsule Summary Approval Date:
Current Status: 7/22/2024 - Study Chair Welcome letters were sent out on 7/18. Planner group has been set up and shared. DSC approved: 7/15/2024 |
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| Lymphoma | ||
| S2308 Randomized Phase III Study of Mosunetuzumab vs. Rituximab for Low Tumor Burden Follicular Lymphoma |
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|
Capsule Summary Approval Date:
Concept or Lol submit to NCI: 02/10/2023 Target Date: 12/05/2023 Drop Dead Date: 08/31/2024
Progress:
504
of 270 days
Current Status: 7/2/2024: Received CTEP approval on hold, finishing up/submitting CIRB amendment review application this week 6/4/2024: CTEP sent one final comment on 6/3 to include in a pre-activation revision. Anticipating activation now towards mid July 5/7/2024: Response was returned to CIRB on 4/24-- had some back and forth on formatting, now anticipating re-review by CIRB by 5/16. Waiting for SDEA and anticipating activation in mid June. 4/3/2024: Had CIRB review meeting about IR. Received comments following week. 3/5/2024: Larry reached out. GNE has one more comment and that they have been delayed in replying to CTEP review. 2/19/2024: resubmitted to CTEP. 2/9/2024: received third round of review comments. 2/6/2024: CTEP has said to anticipate the decision this week (2/5-9). It isn't clear whether this will be an approval or further comment, last review was short. GNE contract and SDEA still in progress. 1/9/2024: Attaching the letter to the top of the protocol and linking then submitting today. 12/26/2023: CTEP sent 2nd round of review comments. Total anticipated accrual: 600. 12/5/2023: GNE fwded comments to ops on 11/28/2023, anticipating a second round of review comments shortly. 11/7/2023: Response to initial CTEP Consensus review was submitted pm 11/6/2023. 10/3/2023: Initial review comments received 10/2. Meeting with team on 10/5 to discuss. Potential meeting with Anna re: imaging budget. 9/5/2023: Submitted to CTEP for initial review on 8/22. 8/1/2023: PRC was completed on 7/5. Pending internal review before submitting to CTEP. 7/11/2023: PRC review occurred on 7/5, Rituximab drug supply conversation began on 6/20. 6/6/2023: Study will not be registrational; RaPID action items ongoing; Targeting PRC in early July. 5/2/2023: RaPID has been scheduled for 5/25, the team has turned in their edits on the first draft, GNE is still internally discussion whether or not to pursue a registration status. 3/7/2023: pending GNE's availability to schedule first Data requirement discussion. Will be looking for team's general availability for the next three weeks as well, and also look to schedule TM talks. 3/10/2023: Steering Committee review |
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| Melanoma | ||
| S2412 Phase III Study of Neoadjuvant/Adjuvant Pembrolizumab versus Adjuvant Pembrolizumab in Resectable Melanoma |
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|
Capsule Summary Approval Date:
Current Status: 07/02/24: The CTEP Review Meeting was held on Wednesday, June 26th. Anticipate CTEP follow-up within the next two weeks. 06/04/24: The CTEP Review Meeting is set for Wednesday, June 26th. Anticipate CTEP follow-up within two weeks post review meeting. 05/07/24: Concept was resubmitted to CTEP on April 22, 2024. Anticipate CTEP follow-up around the fourth week of May. 02/26/24: Committee chair was given guidance from Dr. Blanke to resubmit concept to CTEP with same study number for review with a cover letter stating rational why trial should be considered. 01/22/24: Received CTEP concept disapproval. Administrative Withdrawal/Disapproved decision. 01/09/24: As of today, concept does not have a review date yet. 12/07/23: Concept was submitted to CTEP. Triage capsule approved 8/15. |
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| S2431 Randomized, open-label, phase III study of anti-PD-1, anti-CTLA-4, and anti-LAG-3 antibodies in patients with previously untreated unresectable or metastatic melanoma |
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|
Capsule Summary Approval Date:
Current Status: 7/2/2024: Finishing up concept; goal to submit to CTEP this week 6/4/2024: We determined to submit the concept to CTEP under the assumption that CTEP will still be the IND holder and let them make the final determination themselves since it will otherwise pretty difficult to get the investigative dose covered commercially. 5/7/2024: Drug supply discussions pending, team checking status of BMS support for nivolumab-- F&F invite to be sent for May 20th. |
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| myeloMATCH | ||
| MM1OA-S03 A Randomized Phase 2 trial of C-DEC, venetoclax, and enasidenib compared with azacitidine and venetoclax for newly diagnosed older adults with IDH2 mutant AML: A myeloMATCH treatment trial |
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|
Capsule Summary Approval Date: 09/23/2022
Concept or Lol submit to NCI: 01/31/2023 Target Date: 11/25/2023 Drop Dead Date: 05/23/2024
Progress:
514
of 270 days
Current Status: Minor edits resubmitted 7/10/24. Under CTEP review. CTEP resubmission 6/18/24. NCI Teleconference 3/5/24. Consensus review comments received 2/6/24. Initial CTEP Protocol submisssion 12/07/23. Study team call 12/05. PRC 9/20/23. Edits sent to team 9/26. RaPID 8/8/23. 6/7/2023: LKSC concept approval Scheduling RaPID week of 7/24. 1st draft protocol edits under review 6/6/23. 3/31/23: NCI Teleconference for concept 3/8/23: Concept approval-on-hold (awaiting drug commitments) 2/28/2023: LKSC review. 01/30/2023: LKSC submission 11/01/2022: F&F occurred. 10/06/2022: Risk Assessment Scheduled. 09/23/2022: Capsule triage approved. |
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| Palliative and End of Life Care Committee | ||
| S2408 A Randomized Phase III Blinded Trial of lanreotide for the Prevention of Postoperative Pancreatic Fistula |
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|
Capsule Summary Approval Date: 06/20/2023
Concept or Lol submit to NCI: 12/07/2023 Target Date: 10/19/2024 Drop Dead Date: 07/16/2025
Progress:
185
of 270 days
Current Status: 6/20/2023 Capsule approved by Exec Committee 6/29/2023 Study team working on concept. 7/28/2023 Submitted Initial Concept to DCP 8/21/2023 F&F Call 9/13/2023 Early-Stage Investigator Workshop - Protocol development begins 9/26/2023 DCP Steering Committee Review - Pending status with comments to address 10/12/2023 DCP Comments received. 12/7/2023 Concept resubmitted to DCP. 1/25/2024 DCP approval 3/29/2024 RAPID 4/4/2024 Pre-Launch Meeting in Seattle 4/19/2024 Meeting with DCP to discuss protocol 4/26/2024 Submit for PRC 5/1/2024 PRC Review 5/9/2024 Protocol submission to DCP 5/31/2024 Consensus Review Letter Received - Pending status with comments 6/14/2024 Meeting with Cipla and McKesson to confirm distribution plan 6/30/2024 Protocol Resubmitted to DCP 7/15/2024 Meeting with CCTG to discuss feasibility of opening in Canada |
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| S2418 Distress Screening for Family Caregivers of Persons with Advanced Cancer: The FamilySTRONG Randomized Clinical Trial |
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|
Capsule Summary Approval Date:
Current Status: 8/25/24 - Mini F&F Call. 9/12/24 - Triage approved. Assigned SWOG #S2418 10/15/24 - R01 Submitted by Dr. Odom's Institution. 2/26/24 - The R01 score was good but study is not fundable (21st percentile). The Study Chair will resubmit next cycle. 5/1/24 - Executive Officer notified DCP of resubmission - approved to move forward 7/5/24 - R01 resubmitted by Dr Odom and UAB 11/ 2024 Scientific Review 01/2025 Council Review |
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| S2422 Telehealth Intervention for personalized Self-Management (TIPS) for Eating after Gastroesophageal Cancer Surgery |
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|
Capsule Summary Approval Date: 01/22/2024
Current Status: 01/22/2024 Triage approval received. 02/05/2024 R01 submitted. 06/2024 The R01 was reviewed and scored with an impact score of 29 (14th percentile) - Resubmit next cycle. |
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| SWOG CTP | ||
| 21CTP.Br Molecular assessment and identification of ctDNA and optimizing treatment for HR-positive, Her2-negative metastatic breast cancer |
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|
Capsule Summary Approval Date:
Current Status: 07/01/24: The updated capsule and budget have been submitted to AZ. The study team is pending approval of the capsule/budget and ERC approval. 06/04/24: The updated capsule and budget have been submitted to AZ. The study team is pending approval of the capsule/budget and ERC approval. 05/07/24: Negotiation discussions are ongoing with one of the collaborators (AZ). The study team is pending collaborator approval of the capsule and ERC approval. |
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| 21CTP.HN Phase I/II Study of Amivantamab carboPlatin and pacliTaxel in recurrent metastatic Head and Neck cancer (APT-HN) Study Synopsis |
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|
Capsule Summary Approval Date: 12/01/2022
Current Status: 07/01/24: No new updates. Pending contract execution before protocol development. 06/04/24: No new updates. Pending contract execution before protocol development. 05/04/24: No new updates. Pending contract execution before protocol development. 03/05/24: No new updates. Pending contract execution before protocol development. 02/06/24: Pending contract execution before protocol development. 01/09/24: Pending contract execution before protocol development. 12/01/22: Capsule approved by ERC. |
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| 21CTP.LE A Phase II Trial of Asciminib, Dasatinib, Prednisone, and Blinatumomab for Patients with Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Acute Lymphoblastic Leukemia |
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|
Capsule Summary Approval Date: 02/20/2023
Current Status: 07/01/24- Study team working on CTP Executive Review Responses. 06/01/24- Waiting for CTP Executive Review Responses 5/21/24- CTP Executive Review Committee 4/17/24- PRC Stats Review 03/22/24- 2nd RAPID Call scheduled 02/16/24- RAPID Call scheduled 01/01/24- Working on First Draft Protocol 12/08/23- Contract Execution- 12/08/23 02/20/23- SWOG CTP Executive Review Committee (ERC approved capsule |
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| Symptom Control and Quality of Life | ||
| S2406 Emerging from the Haze (Haze)- A multi-dimensional, psycho-educational, cognitive rehabilitation program to improve perceived cognitive function for cancer survivors [Planning Grant (U34)] |
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|
Capsule Summary Approval Date: 01/15/2020
Current Status: 2/14/24: U34 Resubmission 6/21/23: U34 Submission 1/15/20: Exec. Committee/Triage approved |
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| S2415 Acupuncture to decrease symptom burden in patients with metastatic breast cancer |
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|
Capsule Summary Approval Date: 09/11/2023
Current Status: June 2024 Resubmission 10/5/23: R01 Submission 9/11/23: Triage as FYI 8/16/23: Stats PRC R01 was reviewed on 2/12/24 (Impact score: 42, percentile: 44.0) and was resubmitted in June 2024. |
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