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
Current Status: 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. |
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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: 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: Approved by Triage 1/22/24. R01 submission due 2/5/24. |
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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. Expecting response May/June. |
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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: 3/11/2024- Steering Commitee Approval. |
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| Early Therapeutics & Rare Cancers | ||
| S2310 Phase II Randomized Study Testing Non-Inferiority of Standard Fractionation Versus Shorter-Course Radiation 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
Current Status: 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. 3/4/24 - F&F call 3/29/24 - Concept submitted to CTEP. |
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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: 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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| S2426 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
Current Status: 2/8/24: Triage approved capsule. F & F call- Tentatively scheduled for 3/13/24 |
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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: 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:
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| Gastrointestinal Cancer | ||
| S2303 Phase II/III Trial of Nivolumab + Cabozantinib or Nivolumab + Paclitaxel + Ramucirumab versus Paclitaxel + Ramucirumab in Patients with PD-L1 CPS > 5 Advanced Gastric and Esophageal Adenocarcinoma |
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Capsule Summary Approval Date: 08/15/2022
Concept or Lol submit to NCI: 11/21/2022 Target Date: 09/15/2023 Drop Dead Date: 06/11/2024
Progress:
504
of 270 days
Current Status: 8/8/22 Submitted for Exec Review 8/15/22 Capsule Approved by SWOG 10/24/22 FF Call 11/08/2022 PRO Core 11/21/2022 Concept submitted to CTEP 12/19/2022 Concept review date 1/20/2023 NCI Call 2/6/23 Concept Resubmission 2/27/2023 CTEP Review 3/8/23 CTEP Approval Received 3/8/23 Drug commitment requested from BMS for Nivolumab/Approved 6/6/23 RaPID 7/12/23 PRC pending outcome of RaPID 8/4/23 Submitted Protocol to CTEP. 8/15/23 Permission for PRO Instruments obtained. 8/29/23 Finalizing StRS application for streck tubes. 9/29/23 Meeting with NCI to review Consensus Review Comments 10/11/23 Submitted response to Consensus Review Comments - still at CTEP. 10/11/23 Received NCA draft. Anticipate pre-act. revision to correct the billing issues that were identified. 11/6/23 STrS application reviewed and approved. 11/20/23 Submitted pre-activation revision to address billing concerns/CTEP comments. 12/27/23 CTEP-Approval on hold 01/03/24 CIRB Application submission 01/18/24 CIRB review meeting 02/07/24 CIRB re-submission due 2/15/24 CIRB Approval 3/4/24 CTEP Outcome Letter pending. *Additional NCA billing issues were identified, and the study team will submit a pre-activation revision to correct. 4/10/2024 Pre-Activation Revision Submitted 5/3/2024 Full CTEP approval of Pre-Activation Revision. 5/6/2024 - Activated at 3 PM EST. |
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| 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 |
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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:
322
of 270 days
Current Status: **Planned Activation Date: 06/15/2024** **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. |
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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. Study team has decided to postpone submission to GUSC until Q4 2024 - Osel is conducting a preliminary trial and dose results will be available for CBM-588 at this time. |
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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. |
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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
Current Status: 06/14/2024: LYSC review call scheduled. 04/29/2024: LKSC submittal, pending May review. 04/24/2024: Pharma kick-off call. 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. 04/24/2024: Kick-off call with Eli Lilly 04/29/2024: Submitted to LKSC 05/06/2024: Notified of 6/14 LYSC review, reached out to clarify that it should be LKSC, pending response. |
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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
Concept or Lol submit to NCI: 08/29/2023 Target Date: 01/29/2024 Drop Dead Date: 10/25/2024
Progress:
230
of 130 days
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. |
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| Lung Cancer | ||
| S2313 Neoadjuvant Chemo-durvalumab for Clinical Stage I, 2-3.9cm, Non-small Cell Lung Cancer a Single-arm Trial |
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Capsule Summary Approval Date: 05/04/2023
Current Status: 05/04/23: Exec. Committee/Triage approved. 08/01/23: Study team is working on the LOI for redesign and working on BIQSFP submission. 09/05/23: Study team is reviewing the revised Concept and preparing for further discussions regarding the BIQSFP in anticipation of the TMSC concept submission in mid-October. 10/03/23: Study team is continuing to address Concept revisions and address outstanding questions regarding the study design and the patient eligibility, specimen flow and drug/testing funding. The team has decided to postpone the submission to the TMSC until these questions have been addressed. The Risk Assessment call was held on 09/29 and the F&F meeting is scheduled for 10/06. An additional F&F meeting may be scheduled as needed following the 10/06 meeting. 11/07/23: Study team is continuing to address Concept revisions and provide responses to the TM logistical aspects, including specifications for pCR tissue processing and blood/plasma for ctDNA analysis. The study team held a second F&F meeting to provide responses to the questions on Friday (11/03) but many details still need to be ironed out. The study team is also pending a response from AstraZeneca regarding funding for the neoadjuvant chemo agents and biomarkers tests. We are going to delay submission to CTEP TMSC until December to ensure the TM logistical components are outlined completely in the Concept before the OEWG timeline starts. 12/05/23: The study team is continuing to address Concept revisions and provide responses to the TM logistical aspects, including specifications for pCR tissue processing and blood/plasma for ctDNA analysis. The study team still anticipates a submission to CTEP TMSC by 12/14, as we plan to proceed with the understanding that AstraZeneca will fund the neoadjuvant chemo agents and biomarker tests. 01/09/23: It was determined right before the holidays that AstraZeneca would not be able to proceed with support of the concept as their internal priority/strategy on the stage I NSCLC disease setting has shifted over the last year and the current proposal doesn’t align with their mission moving forward into 2024. That said, the study chairs are pursuing discussions with other pharma partners (including Merck) to identify funding support for the neoadjuvant chemo agents as well as the biomarker tests. The concept will undergo some revisions in the coming weeks to reflect the changes in study design as conversations develop with the pharma groups in hopes of receiving the financial support needed in order to submit the concept to CTEP in Q1 2024. 02/06/24: The study team is continuing to refine the concept and develop budget estimates following the January 10th teleconference with Merck. A follow up call is scheduled with Merck for Wednesday, February 7th for further discussion on study redesign details, including the consideration for a single arm, phase II trial with pCR as the primary endpoint. Additional meetings for funding support are being considered with Genentech and Regeneron. 03/06/24: The study team is continuing to hold discussions with other potential collaborators (Genentech, Regeneron, etc.) for funding support. 05/07/24: Verbal commitment received from Regeneron last week. Next steps include updating the Concept with the new agents and conducting Regeneron's full review/sign-off of the Concept design. |
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| S2404 Accelerating Drug Efficacy Evaluation thru Growth Rate and Overall Survival Correlations |
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Capsule Summary Approval Date: 06/02/2023
Current Status: 04/19/24 - Responses and budget submitted to CTIU 03/25/24 - The NCI CTIU reciewed the consensus summary provided by the Cancer Imaging Steering Committee. 02/20/24 - The proposal will be reviewed by the NCI Clinical Imaging Steering Committee (CISC) CTIU had an informal review with the FDA and provided the study team with feedback 10/10/23 - Study team submitted responses. 10/03/23 - The study team is addressing comments with re-submission due 10/10. 07/13/23 - CTIU Proposal Submission We are in communication with the study team on scheduling a call to further discuss the proposal in August. (CTIU 23-4 and 23-14) |
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| S2409 PRISM: A Multicohort PRecIsion SCLC Subtype Maintenance Phase II Trial of Durvalumab Versus Biomarker-Directed Novel Agents in Combination with Durvalumab in 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:
146
of 180 days
Current Status: 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 The protocol draft will be distributed to the team before the RaPID call on May 17, 2024. RaPID #2 is currently being scheduled. 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:
174
of 180 days
Current Status: 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 Study team is scheduling a call with Jubilant drug company to discuss the details related to obtaining a CRADA. |
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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:
230
of 270 days
Current Status: 03/08/24: Target 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:
174
of 270 days
Current Status: OEWG start date: 11/16/23 Drop Dead date: 5/9/25 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: 05/11/2024
Progress:
447
of 180 days
Current Status: Target activation: OEWG Drop Dead 5/11/24, extension request pending 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: 5/7/24 - The study team is awaiting a final decision from Daiichi Sankyo regarding their review of the concept. CTEP pre-look submission anticipated in May. 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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| 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:
425
of 270 days
Current Status: 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: 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: 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 | ||
| MM10A-S02 A Phase II Study of Targeted Agents with the Oral DNMT1 Inhibitor Cedazuridine-Decitabine (ASTX727) for the Treatment of Newly Diagnosed TP53-Mutated Acute Myeloid Leukemia in Older Patients: A myeloMATCH Treatment Trial |
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Capsule Summary Approval Date: 01/04/2022
Concept or Lol submit to NCI: 01/04/2022 Target Date: 10/01/2022 Drop Dead Date: 11/20/2023
Progress:
855
of 270 days
Current Status: Requested protocol withdrawal from CTEP 5/2/24. Discussions ongoing regarding Magrolimab (FDA hold); Study under review/on hold at CTEP. RRA rec'd 1/23/24. No action until we hear from CTEP. myeloMATCH OEWG timelines suspended. Consensus review rec'd 9/11. CTEP resub 9/15. Consensus review rec'd 8/14. CTEP resub 8/28. Consensus review rec'd 6/26. Resub week of 7/10. Consensus review rec'd 3/30/23. Resub 4/25/23. *Updated* consensus rec'd 2/7/23. CTEP resub 2/13/23. Updated consensus review received 12/29/2022. CTEP resub 2/6/23. NCI call occurred 12/19/2022. CTEP consensus review received 11/22/2022. CTEP submission 10/17/2022. PRC 09/14/2022. RaPID completed 08/29/2022. Concept approval on hold, OEWG call 2/8/22. LKSC: 01/04/2022 Concept submission: 11/02/2021 F&F 10/18/21. Risk assessment 10/7/21. Triage approval 9/27/21. |
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| 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:
435
of 270 days
Current Status: NCI Teleconference scheduled for 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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| MM1YA-S01 A Randomized Phase II Study of Novel Therapeutics in Younger Patients with High-Risk Acute Myeloid Leukemia |
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Capsule Summary Approval Date: 12/08/2020
Concept or Lol submit to NCI: 07/10/2021 Target Date: 08/22/2021 Drop Dead Date: 09/15/2023
Progress:
1170
of 180 days
Current Status: CIRB approval received: 2/13/24. Resubmitted to CTEP 01/30/24. CIRB Amendment App 1/31. myeloMATCH OEWG timelines suspended. CTEP comments rec'd 01/02/24. 11/21/23 version resubmitted to CTEP 12/4/23 CIRB approval 9/19/23. CIRB amendment app 8/29/23. Resub to CTEP 8/22/23 (v9). OEWG timeline extended to 9/15/2023. Extension expected. CIRB resub 5/31/2023. CIRB approval 6/21/23. Working on company comments for CTEP. CIRB amendment application 5/2/23. CTEP resub 4/13/23 (with Arm 5). CTEP approval on hold 4/26/23. Updated Schema received 01/06/2023. CTEP resub 2/21/23. Withdrawn. New review received 12/29/2022. CTEP approval on hold received 12/20/2022. Waiting on final approval - pre-activation revision is pending. CIRB re-submission due 10/05/2022. CIRB approval received 10/14/2022 CIRB initial application due 09/7/2022. CTEP approval on hold 09/02/022. OEWG timeline for MATCH extended until October 2022. CTEP resub 6/26/22. CTEP re-submission 2/1/2022. Responses rec'd 2/24/22. NCI Teleconference 1/10/2022. CTEP review 12/2/21. Protocol submitted to CTEP on 11/12/21. PRC held on 9/22. Post-RaPID protocol draft distributed. RaPID held on 07/20/21. Approved by Steering Committee 7/27/2021. Consensus review response to concept review submitted 06/09. |
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| MYELOMATCH Master Screening and Reassessment Protocol (MSRP) for the NCI myeloMATCH trials |
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Capsule Summary Approval Date: 03/03/2021
Concept or Lol submit to NCI: 07/10/2021 Target Date: 09/21/2021 Drop Dead Date: 09/15/2023
Progress:
1140
of 180 days
Current Status: Pre-Activation revision sub 5/1/24. Expedited review requested. CIRB approval received: 2/7/24. Resubmitted to CTEP 01/22/24. CIRB Amendment app 1/29. CTEP comments rec'd 01/02/24. MSRP/TAP resub to CTEP 12/01/23. myeloMATCH OEWG timelines suspended. myeloMATCH team working on TAP integration. In-person review 6/3/21. CIRB approval 5/31/2023 CIRB amendment application submitted 5/2/23. CTEP approval on hold 4/27/23. Consensus rec'd 3/29/23. Resub by 4/7/23. CTEP resub 2/21/23 Awaiting Help Desk Contact Information and OEWG timeline extension. 6/16/2023. New review received 12/29/2022. Pathology forms received 01/06/2023. CTEP approval on hold 12/20/2022. Waiting on final approval - pre-activation revision is pending. CIRB approval received 10/14/2022 CIRB initial application due 09/07/2022. CTEP approval on hold 09/02/2022. CTEP resub 4/26/2; 6/28/22. CTEP re-submission 1/26. Responses received 2/25. NCI Teleconference 1/11/22. Protocol submitted to CTEP on 11/12/2021. RaPID for 09/17/21. PRC held on 9/29/21. Protocol Draft circulated to study team 04/01/21. MSRP Concept approved 04/05/21. NOTE: MSRP is not subject to OEWG timeline |
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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:
106
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 Concept to DCP 8/21/2023 F&F Call - scheduling separate KOC call with Cipla. 9/13/2023 Early-Stage Investigator Workshop - Protocol Development 9/26/2023 DCP Steering Committee Review - Outcome is "Pending". 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 |
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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 - Mini F&F Call. 9/12 - Triage approved. Assigned SWOG number S2418. 10/15 - 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 - Executive Officer notified DCP of resubmission. 7/5/24 - Study Chair to resubmit R01. |
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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. |
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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: 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.GU Multi-Arm Phase II Trial Comparing Standard of Care Chemotherapy to Subtype-Directed Therapy in Predicting Response of Muscle Invasive Bladder Cancer (SUBTYP) |
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Capsule Summary Approval Date:
Current Status: 3/5: As of today, have not heard anything back yet. 2/22: During scientific call with GNE and Tempus, it was hinted that GNE will be conducting an internal review of the study as part of their internal budgeting process. Said they were presenting on Monday (2/26). |
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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: 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: 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 will be resubmitted in June 2024. |
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