Protocol Tracking Reports: Dashboard
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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:
Drop Dead Date: 06/12/2025
Current Status: 12/3/24: Protocol is with DCP. I expect to hear back by 12/13 or 12/16. (Usual turnaround is 45 days). 10/30/24: Protocol submitted to DCP. Target deadline is 4/23/25. Absolute Deadline is 6/12/25. 10/9/24: Protocol and documents to be reviewed by Stat Center PRC. Protocol due on 10/30/24. 9/23/24: Had Rapid #2. 9/6/24: Had Rapid #1. 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:
Drop Dead Date: 10/12/2025
Current Status: 12/13/24: Goal is to get the pre-RAPID study draft to the team prior to the holidays. 12/3/24: Received first draft of protocol and MCF. Asked Dr. Parikh to forward NOA document. 11/5/24: Drafting timeline. Drafting Study Assumptions Worksheet. Setting up poll for biweekly study team calls. Need to do: schedule risk assessment with Dana and set up F&F call, Start working on "Study Descriptions to facilitate PRO Permissions" spreadsheet. 10/29/24: Study chairs received their Just in Time request. Grant start date will likely be 12/1/24. (if grant start date is 12/1/24, looking at target activation of August 2025, and absolute deadline of October 2025. 9/9/24: Sent protocol template to study chairs. 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. 1/22/24: Approved by Triage. 11/14/23: PRO measures reviewed by PROCore Team. Recommendations distributed to study chairs on 11/15/23. |
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| comboMATCH | ||
| EAY191-S7 A Phase 2 Study Investigating Safety and Efficacy of Trastuzumab Deruxtecan (DS8201/T-DXd) and ATR Inhibitor, Ceralasertib (AZD6738) in Human Epidermal Growth Factor Receptor 2 (HER2) Positive Advanced Solid Tumors. |
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Capsule Summary Approval Date:
Current Status: 12/06/24: Approved by the ComboMATCH Steering Committee. Pending Triage FYI submission and CTEP Steering Committee Submission. |
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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: 12/03/24: The Concept draft was reviewed by SWOG Ops late last month where several questions were identified for the study team to address. Concept submission timing to CTEP is still pending Committee Leadership prioritization. 11/05/24: Concept draft was finalized and approved by the ETxRC Committee Leadership in late October. Currently awaiting submission to CTEP PIO once an open slot is available in the ETxRC Committee priority list as there are currently 3/3 studies on an OEWG timeline. 10/01/24: The NCI Neuroendocrine Taskforce Review was held last month (09/05) and the Concept received favorable remarks. Dr. Sukrithan is taking the NCI Taskforce Review comments to make additional revisions to the Concept prior to it being ready for CTEP submission. 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: 11/18- Dr. Ang sent Dr. Chen an email if we might be able to access dabrafenib and trametinib through CTEP. Pending a response. 11/15/24: Study team met to discuss next step forward. Approach CTEP about possibility of CTEP supplying 2 of 3 study drugs. 11/13/24: Pfizer decided not support study. 10/30/24: Call with Bayer team. The study is supported generally, Bayer can only provide drug support not financial support. 10/8/24: Call with Pfizer team. The concept has to go through 2 internal reviews before a decision of support will be made. 10/1/24: Scheduled call with Pfizer 10/8/2024, Bayer call is being scheduled Oct, Pending F & F call scheduling (will be circulating scheduling poll this week) . 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: 12/03/24: Concept disapproval notification was received from CTEP on 11/12. The study team is organizing a call with CTEP to discuss their comments further. 11/05/24: Concept was reviewed by CTEP on 10/31. We anticipate receiving CTEP Review Comments within the next two weeks. 10/01/24: Concept was submitted to CTEP PIO on 09/16. Anticipate CTEP Review Comments within the next 6-8 weeks. 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: 01/12/2025 Drop Dead Date: 10/09/2025
Progress:
158
of 180 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 8/7/2024: responses and updated concept submitted to CTEP 9/6/2024: received CTEP approval on hold with comments 9/23/2024: protocol working draft circulated to Study Chairs and SDMC 9/30/2024: concept approval 10/8/2024: receipt of concept approval 10/29/2024: RaPID meeting scheduled for 11/8/2024 11/8/2024: PRC 11/21/2024: updated draft sent to SDMC for PRC 11/27/2024: PRC 12/2/2024: received study chair post-PRC edits |
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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
Concept or Lol submit to NCI: 06/10/2024 Target Date: 04/11/2025 Drop Dead Date: 01/06/2026
Progress:
159
of 270 days
Current Status: 11/1/23 - Preliminary meeting with Amgen 4/1/24 - Approved by SWOG Executive Committee and awarded # S2433. 5/3/24 - Study Team Kick off meeting 6/10/24 - Submitted concept to GISC 6/14/24 - F&F Call 6/14/24- Received PRO Core feedback. 6/26/24 - KOC with Amgen 7/15/24 - Review by GISC - Outcome is pending, with comments to address. 8/12/24 - Meeting with NCI to discuss feedback. 8/30/24 - Concept resubmitted. 9/16/24- final GISC review. 10/07/24 - GISC Approval of concept. 10/17/24 - Meeting with Vonda from Amgen to discuss updates to study design/timeline 10/24/24 - Touchbase Call with Amgen 11/07/24 - Initiate Study Team Calls 12/04/24 - RaPID Call 01/08/25 - Stats PRC 01/2025 - 02/2025 - Protocol Submission to PIO |
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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
Concept or Lol submit to NCI: 07/26/2024 Target Date: 06/15/2025 Drop Dead Date: 03/12/2026
Progress:
94
of 270 days
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. Concept reviewed by GUSC on 9/18. Pending decision received 10/7. Resubmitting on 11/6 for the 11/20 GUSC review date. Reviewed on 11/20. Pending final outcome. |
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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
Concept or Lol submit to NCI: 05/28/2024 Target Date: 01/13/2025 Drop Dead Date: 10/10/2025
Progress:
157
of 180 days
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. GUSC approved concept 9/5. Awaiting drug commitment from Merck (CTEP CRADA). Drafting protocol and RaPID call scheduled for 11/6. MERCK committed to supplying drug on 10/19. Scheduling PRC for mid to late January. |
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| Leukemia | ||
| 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. 10/01/2024: Pharma Kick-off Call with Sumitomo scheduled. 10/31/2024: Risk Assessment completed. 11/19/2024: F&F call occurred. |
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| S2504 A Randomized Phase III 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: 09/13/2024 Target Date: 08/05/2025 Drop Dead Date: 05/02/2026
Progress:
43
of 270 days
Current Status: PRC scheduled for: 2/12/25. RaPID scheduled for: 1/24/25 Protocol first draft sent 12/17/24. Concept approval 12/5/2024. S2504 concept submitted 9/13. Reviewed by LYSC on 11/08. S2421 concept was withdrawn, edits made, new study # is S2504. 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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| Lung Cancer | ||
| CTIU2317 Perioperative Versus Adjuvant Systemic Therapy in Patients with Resectable Non-Small Cell Lung Cancer - PROSPECT LUNG |
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Capsule Summary Approval Date:
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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:
373
of 180 days
Current Status: 11/15/24: Follow Up Responses to CTEP Submission 10/30/24: Received Follow Up Comments from CTEP 10/14/24: Responses to CTEP Consensus Review and Protocol Submission 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; CTEP is currently reviewing our responses. We will provide further updates as soon as we receive their feedback. |
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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:
457
of 270 days
Current Status: Drop Dead: March 14, 2025 Target Activation: 2/1/25 11/27/24: CTEP 3rd Responses Submitted 11/15/24: Received CTEP 3rd Consenus Review Comments 11/05/24: CTEP is reviewing AZ comments. Study team is following up weekly. 10/01/24: CTEP/AZ requesting a call to discuss comments 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 investigators 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
Current Status: 8/26/24: Exec. Cmte/ Triage Approved 11/8/24: Meeting with Jubilant and Dr. Starodub, who shared insights on his experience with the drug and protocol. Note: Formally, S2410 concept was disapproved by CTEP due to drug company support withdrawal. The study chairs are currently awaiting Jubilant's Phase I data and additional information regarding the clinical studies of the LSD inhibitor. These updates will guide the next steps for the study. |
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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:
401
of 270 days
Current Status: OEWG start date: 11/16/23 Drop Dead date: 5/9/25 Target activation: 1/15/25 12/16/24 - Several legal items are being discussed in the contract. The contract is with the SWOG legal team for review, and it will be sent back to Regeneron soon. Based on current information, the activation target for S1800E has been moved to 1/15/25. 12/3/24 - Legal teams are meeting on 12/5/24 to discuss the contract. Contract execution is anticipated the week of 12/9/24. Target activation 12/16/24. 11/5/24 - RAVE build completion anticipated 12/2/24. CTEP Full Approval is pending contract execution, and contract negotiations are underway. Activation is anticipated in December. 10/1/24 - PMB has received the cemiplimab supply. Contract negotiations are underway. RAVE build completion anticipated in December. SDMC will determine if they can accelerate this target. Activation is anticipated by the end of this year. 9/16/24 - Formal FDA meeting. No protocol updates were required as a result of the FDA comments and meeting. 9/13/24 - Responded to preliminary meeting comments from the FDA 9/11/24 - Received CIRB Full Approval of Initial Review. Received preliminary meeting comments from the FDA. 8/30/24 - Submitted response to CIRB Initial Review comments. CIRB approval anticipated in September. 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 |
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| S1900N A Randomized Phase II Study of Sacituzumab Govitecan and Ivonescimab or Sacituzumab Govitecan or 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: 07/15/2024
Current Status: 12/2 - CTEP Pre-Look comments received on 11/21. ST met on 11/25 to discuss and are currently updating concept. Collaborators updated on 11/25 that ST is reviewing. 11/4/2024 - ST incorporated Sponsor feedback and concept submitted for CTEP Pre-Look on 10/28. CTEP response expected mid-November. Internal risk assessment planned on 11/6. Gilead's main concerns: Timeline and budget. Summit's main concerns: data outcome for Ivonescimab. 10/23/2024 - Summit proposed change to a 3-arm design that includes an Ivo-only arm. Study Team discussed with Gilead/Summit and has sent them the new concept design for review on 10/22. 9/30/2024 - Concept draft submitted for pharma review on 9/13. Study Team working on Gilead's review comments and awaiting Summit's review. 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: 03/26/2024
Concept or Lol submit to NCI: 08/09/2024 Target Date: 07/15/2025 Drop Dead Date: 04/11/2026
Progress:
64
of 270 days
Current Status: 11/15/24: Meeting with CTEP; study team working on finalizing responses and updates to submit by end of week (12/6) 10/18/24: CTEP approval pending modifications 10/1/2024: CTEP will review on 10/16 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:
662
of 270 days
Current Status: Pre-activation revision #1: CIRB approval rec'd 12/9/24. FDA review comments rec'd 11/27. Edits due EOB 12/10. CIRB comments rec'd 11/14. Resub 11/21. CTEP AOH 10/23. CIRB Initial App 10/24 for 11/7 CIRB review. CTEP comments rec'd 9/27. Resubmitted 10/11. CTEP comments rec'd 8/30. Protocol resubmited to CTEP 9/13. Aiming for October CIRB review. 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: 07/28/2023 Target Date: 10/15/2024 Drop Dead Date: 02/18/2025
Progress:
512
of 445 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. 10/1/2024 DCP Approval on Hold 10/9/2024 Submission to CIRB 10/24/2024 CIRB Review 11/08/2024 Resubmit to CIRB 11/11/2024 CIRB approval 11/21/2024 DCP Full Approval 12/06/2024 *Targeted Contract Completion with Cipla 12/09-12/13/24 *Targeted Subcontract Completion with McKesson |
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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 11/26/2024 Scientific Review - Summary statements have been received, highlighting concerns regarding the lack of preliminary efficacy data and the feasibility of the trial within the SWOG Network. Next steps will be discussed over the coming month. 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) 11/05/2024 R01 resubmitted |
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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: 12/03/24: The study team is working on CTP ERC responses. 11/01/24: The study team is working on CTP ERC responses. 10/01/24: Received CTP ERC Capsule Outcome Review Letter on 09/23/24. The study team is working on responses. 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: 12/03/24: Stats PRC review is scheduled for Wednesday, December 18th. 11/01/24: RAPID Call is scheduled for Friday, November 15, 2024. Invite has been circulated. 10/01/24: Finalizing the pending contract execution before protocol development. 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: 12/03/24- Awaiting to hear back from FDA, then will submit to WCG IRB. Targeting end of Q1 2025 activation. 11/01/24- Pre-Activation Revision #2 is under internal review. 10/01/24- Currently working on Pre-Activation Revision #2. 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-Activation 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 | ||
| 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: 10/17/24: R01 was reviewed (Score 31, Percentile: 15.0) 6/4/24: R01 Resubmission 10/5/23: R01 Submission 9/11/23: Triage as FYI 8/16/23: Stats PRC Close to fundable, but likely requires NCI advocacy to secure funding. Study chair will await NCI comments expected late November 2024 (~6 weeks). Potential resubmission in February 2025. The study has been moved to the Palliative and End of Life Committee but will remain under the Symptom Management & Survivorship Committee until the R01 is approved. |
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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 Call scheduled w/ NCI leadership on 10/11 to address summary statement concerns. On track to resubmit the R01 this month. R01 resubmitted in November. |
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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. Reassigned to a special panel that will meet on 11/21. Initial result expected soon after and comments expected late December. |
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