Protocol Tracking Reports: Dashboard
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| Breast Cancer | ||
| S2501 ARIA: A Randomized Phase III Trial of Abemaciclib versus Ribociclib In the Adjuvant Treatment of High-Risk, Hormone-Receptor Positive Early-Stage Breast Cancer |
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Capsule Summary Approval Date: 07/26/2024
Current Status: 07/26/2024: Capsule received Triage approval. 08/05/2024: F&F call pending scheduling. 08/27/2024: F&F call occurred. Aiming for BCSC submission by 9/17 for 10/15 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: 9/6/24: Rapid call scheduled. Protocol due to DCP 10/30. Having weekly study team calls every Friday. 8/5/24: Follow-up notes from F&F distributed. 8/1/24: Had F&F call. NOA grant start date is 8/1/24. 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: 8/1/24: Dr. Parikh hosted R01 check in. Went over next steps. Awaiting estimate for NOA (grant start date). Dr. Castro to host R01 expectations call in October. 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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| 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: 9/03/2024- CTEP Concept Call scheduled September 6th. 08/06/2024- CTEP Consensus review comments received, a call schedule with CTEP on 8/12. 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 | ||
| 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: 09/03/24: Dr. Sukrithan presented the Concept draft to the Community Advocacy Committee earlier this morning and received their constructive feedback and overall approval of the study design. The NCI Neuroendocrine Taskforce will review the Concept draft on Thursday (09/05) for their feedback ahead of CTEP submission. Dr. Sukrithan was not successful in achieving industry funding support for the streck tubes for the liquid biopsy collection so he has determined that his institution (OSU) will cover the costs. Next steps will be to work with ETxRC Committee Leaderships to determine the timing of the Concept submission to CTEP. 08/06/24: Dr. Sukrithan will present the current draft Concept to the NCI Neuroendocrine Taskforce on 09/05 for their review ahead of CTEP submission. Dr. Sukrithan continues to seek funding for the streck tubes for the liquid biopsy collection, including outreach to Natera and Tempus as potential collaborators based on the feedback received from the GI Net Subcommittee review meeting last month. Timeline for CTEP submission will be determined with committee leadership following the Neuroendocrine Taskforce review of the Concept. 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: 09/03/24: The S2432 Concept draft was reviewed by BMS on 08/06 and received positive feedback and verbal support for the study design. The Patient Advocate Committee reviewed the Concept draft on 08/28 and also received positive feedback from this group and offered to provide a Letter of Support to include with the submission to CTEP. Next steps include final internal (SWOG Ops) review of the Concept draft and discussion of submission timing to CTEP with the ETxRC Committee leadership. 08/06/24: The F&F meeting was held on 07/30 where it was confirmed that the overall study design, including the TM components for specimen collection will remain the same as S1609. During the F&F meeting the following points were also noted: 1. Need to determine if the CTEP/BMS CRADA allows for international distribution of the Nivolumab and Relatlimab agent combo. 2. NCI Coverage Analysis for S1609 should be reviewed in preparation for the S2432 budget development considering the unique/rare disease codes required for the trial. Dr. Chae and the study team will also be meeting with BMS later today (08/06) to confirm their support for the Concept prior to CTEP submission. 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:
53
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 Randomized Phase III Study of Second-Line Chemotherapy with or without Panitumumab for Locally Advanced or Metastatic KRAS 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 - Outcome is pending, with comments to address. 8/12 - Meeting with NCI to discuss feedback. 8/30 - Concept resubmitted. 9/16- final GISC review. |
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| Genitourinary Cancer | ||
| 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. Osel wants to pursue registrational intent with the FDA for this trial. Concept submitted to GUSC on 7/26 for 9/18 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. Received a "pending" decision on 7/17. Study team will respond to major comments and update concept by 8/7 for 8/21 GUSC review. Study will continue to be on the OEWG timeline for the original review date (6/26). GUSC re-reviewed concept and responses to major comments on 8/21 call. Awaiting decision. |
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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: 03/11/2025 Drop Dead Date: 12/06/2025
Progress:
85
of 270 days
Current Status: Concept resubmitted 8/20 for 9/13 LYSC review. 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
Concept or Lol submit to NCI: 08/27/2024
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 occurred, study team is making modifications to the LOI, blinatumomab will now be be CIV only and commercially supplied. Accrual has changed to 52. 08/27/2024: LOI submitted to LKSC. |
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| S2502 A Phase I/II study of TP-3654 in Combination with Decitabine for Myelodysplastic syndrome/myeloproliferative neoplasm overlap syndromes (MDS/MPNs) and Accelerated- or Blast-Phase MPNs (MPN-AP/BP) |
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Capsule Summary Approval Date: 08/19/2024
Current Status: 08/19/2024: Capsule Approved by Triage. 09/06/2024: Internal Study Team Call scheduled, Pharma kick-off call and F&F pending scheduling. |
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| Lung Cancer | ||
| 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:
268
of 180 days
Current Status: 9/11/24: NCI Teleconference to discuss Consensus Review 8/30/24: Distributed NCI Consensus Review Comments 8/1/24: Initial Protocol CTEP Submission 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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| 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:
352
of 270 days
Current Status: 09/03/24: Pending CTEP response 08/08/24: CTEP 2nd Responses Submission 07/18/24: Received 2nd CTEP Consensus Review 06/06/24: CTEP Responses Submitted 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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| S2503 A randomized phase II study of atezolizumab and JBI-802 versus investigator’s choice of standard of care for second or third 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:
296
of 180 days
Current Status: 8/26/24: Exec. Cmte/ Triage Approved Note: Formally, S2410 concept was disapproved by CTEP due to drug company support withdrawal. We have circulated the concept for team review prior to submitting to CTEP. Genentech is currently still reviewing the budget and updated concept. Once the review is complete, Anna will circulate the finalized budget and STrS forms. |
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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: 05/09/2025
Progress:
296
of 270 days
Current Status: OEWG start date: 11/16/23 Drop Dead date: 5/9/25 Target activation: 11/1/24 8/30/24 - Submitted response to CIRB Initial Review comments. CIRB approval anticipated in September. The formal FDA meeting will take place on 9/16/24. Activation is targeted 11/1/24 (end of this year). 8/31/24 - CIRB Initial Review comments received 8/15/24 - CIRB Initial Review 7/26/24 - Initial CIRB submission made.The CIRB Initial Review date is 8/15/24. Anticipating CIRB review comments in late August. 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:
569
of 180 days
Current Status: Original OEWG Drop Dead 5/11/24, second OEWG Drop Dead 7/26/24, current OEWG Drop Dead 9/27/24 Target activation: 9/25/24 9/5/24 - CIRB Review of S1900J pre-activation revision 8/7/24 - Pre-activation revision submitted to CIRB 7/30/24 - Submitted Follow-up Review response to CTEP 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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| S1900N A Randomized Phase II Study of Sacituzumab Govitecan with or without Ivonescimab in Participants with Previously-Treated Actionable Genomic Alteration Positive Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Sub-Study) |
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Capsule Summary Approval Date:
Current Status: 8/30/2024 - Internal Kick off Call held 8/30. Concept draft still in development with Study Team. 8/14/2024 - Concept draft expected by 8/31 from study team. 8/5/2024 - Admin Kick-Off call held on 8/5 with both Gilead and Summit. Scientific Kick-off call scheduled for 8/9. Internal call for Concept development scheduled for 8/8. 7/30/2024 - Admin Kick-Off Call scheduled for 8/5. Scientific Kick-Off Call scheduled for 8/9. 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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| Melanoma | ||
| 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: 8/9/2024: Concept submitted to CTEP 8/6/2024: Concept sent to committee leadership for approval 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:
557
of 270 days
Current Status: CTEP comments rec'd 8/30. Plan to resubmit by 9/13. Protocol resubmitted to CTEP 8/12. CTEP comments rec'd 7/29/24. Resubmission due 8/12 (2 weeks). 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:
228
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 7/23/2024 Received DCP Consensus Review Letter -Pending Status with 1 comment. *We are removing the administrative Step 2 registration step to simplify the design based on feedback. 8/29/2024 Letter of Support from SWOG to CCTG. *CCTG is applying for grant funding for participation and is requesting drug supply from Ipsen. 9/22/2024 Re submission is due 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: 8/25/2023 - Mini F&F Call. 9/12/2023 - Triage approved. Assigned SWOG #S2418 10/15/2023 - R01 Submitted by Dr. Odom's Institution. 2/26/2024 - The R01 score is not fundable (21st percentile). Will resubmit. 5/1/2024 - Executive Officer notified DCP of re submission - approved to move forward. 7/5/2024 - R01 resubmitted by Dr Odom and UAB 10/17/2024 - Pre - Launch Meeting in Chicago 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: 09/03/24: CTP ERC reviewed the concept on 8/20, pending ERC review letter. 08/06/24: The capsule will be presented to CTP ERC on 8/20 for their review. 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: 09/03/24: No new updates. Pending contract execution before protocol development. 08/06/24: No new updates. Pending contract execution before protocol development. 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: 09/03/24- FDA review comments responses submitted; updated protocol will be re-submitted by 9/9. 08/06/24- Study team received Approval on hold letter on 7.29.24. Currently working on Pre-Activtion Revision #1. Site Selection letters have been sent out. 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: 9/11/24: Summary Statement U34 Follow-Up Call 7/8/24: The U34 resubmission was recommended for triage by a reviewer, so we need to wait for the summary statements to discuss next steps within SWOG. 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: 6/4/24: R01 Resubmission 10/5/23: R01 Submission 9/11/23: Triage as FYI 8/16/23: Stats PRC |
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| 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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