Protocol Tracking Reports: Dashboard
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| Breast Cancer | ||
| S2511 Randomized Phase III trial of multimodality therapy versus standard of care systemic therapy in HER2 positive (HER2+) de novo (AJCC stage IV) oligometastatic breast cancer with response to initial chemotherapy |
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Capsule Summary Approval Date: 04/07/2025
Concept or Lol submit to NCI: 05/16/2025 Target Date: 03/14/2026 Drop Dead Date: 03/09/2027
Progress:
358
of 270 days
Current Status: 06/02/2026: CIRB approval was received on 05/18. Currently pending full CTEP approval and remain on target for 06/15 activation. 04/07/2026: Resubmission to CTEP addressing their Consensus Review was completed on 03/19. CTEP Approval-on-Hold status received on 04/03. Initial CIRB submission completed 04/07. 03/03/2026: CTEP Steering Committee review held on 02/19. CTEP Consensus Review comments were received on 02/25. The study team is currently addressing CTEP's comments as we work toward resubmission within the next two-weeks. 02/03/2026: The initial CTEP submission was completed on 01/28. Currently pending CTEP Consensus Review comments. 01/06/2026: PRC edits were received from SDMC on 12/13. The post-PRC protocol version was shared with the study team on 12/15 for review and final revision recommendations. Nationwide and IROC are also reviewing the post-PRC protocol with edits due this week. We are targeting submission to CTEP within the next 2–3 weeks. 12/02/2025: PRC set for 12/03; initial CTEP submission targeted for late December or early January. 11/04/2025: RaPID held on 10/30, ICD review set for 11/05, PRC scheduled for 12/03. 10/06/2025: RaPID call scheduled for 10/30; ICD Review scheduled for 11/05. 07/18/2025: BCSC approval received, RaPID call is pending scheduling. 07/01/2025: Pending receipt of the concept review comment(s)/decision. 06/17/2025: BCSC concept review scheduled. 05/16/2025: Concept submitted to BCSC. 05/13/2025: F&F Call occurred. 04/07/2025: Capsule Approved; Study Team Kick-off scheduled for 04/28. |
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| comboMATCH | ||
| EAY191-S9 Phase 2 study of Inavolisib in combination with Ribociclib in PIK3CA aberrated Head & Neck + GYN cancers |
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Capsule Summary Approval Date: 08/11/2025
Concept or Lol submit to NCI: 11/21/2025 Target Date: 05/23/2026 Drop Dead Date: 05/18/2027
Progress:
198
of 180 days
Current Status: 6/2/26: Pending drug commitment from Novartis. Per Novartis, the concept must go through multiple levels of internal review. Novartis is unable to provide a timeline for the review process. Still working on scheduling RaPID; trying to schedule for June but having difficulty with SC availability. Since the previous call we received approval from CTEP to add a NSCLC cohort post-activation. 4/7/26: Study team is working on first draft of protocol. Scheduling for study team KOC and RaPID in progress. Still pending drug commitment due to incorrect email addresses. 3/20/26: Concept approved by CTEP, pending drug commitment from GNE and Novartis. 2/20/26: Additional comments from CTEP received. Study team is working on edits. The concept will be resubmitted by 3/6/26. 1/26/26: Revised concept submitted to CTEP. 1/9/26: Conference call with CTEP. 12/16/25: Consensus review comments received from CTEP. CTEP identified "major issues that require further consideration" prior to concept approval. 11/24/25: Concept presented to SWOG exec committee (as an FYI) 11/21/25: Concept submitted to CTEP 10/15/25: Concept reviewed by stats PRC 8/11/25: Concept approved by ComboMATCH steering committee |
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| Early Therapeutics & Rare Cancers | ||
| S2505 Phase III Randomized Study Testing Non-Inferiority of Short-Course Ultra-Hypofractionated Radiation (UHRT-5) Versus Standard Fractionation (RT-25) for Stage II-IIIB, Extremity, Resectable Soft Tissue Sarcoma |
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Capsule Summary Approval Date: 11/06/2024
Concept or Lol submit to NCI: 02/12/2025 Target Date: 01/30/2026 Drop Dead Date: 12/02/2026
Progress:
401
of 270 days
Current Status: 5/27/26: Submitted study chair responses was submitted to CIRB. Activation scheduled 7/1/26. 4/03/26: CIRB Initial Application submitted 4/02/26: CTEP approval on hold 3/24/26: Submitted revised protocol, consent, PI response to CTEP. 2/27/26: Received comments on protocol from NCI, team is working on response plan to send response to NCI by next week. 2/3/2026: Finalizing PI response to NCI consensus review comments, plan to resubmit to CTEP this week. 1/5/2026: STrS application was disapproved by triage/ Imaging proposal was approved by triage and will be be added to current version of the protocol. 12/15/2025: Received CTEP consensus comments. 12/2/2025: CTEP had a scheduled review 11/26/25, pending comments. 11/4/25: Pending CTEP consensus review comments on protocol and consent. Imaging proposal is pending triage review. 9/18/25: Protocol and consent have been submitted to CTEP for initial review. 9/2/25: Finalizing protocol and consent for initial CTEP review, plan is to submit next week. 8/5/25: 2nd call RaPID calls was completed 7/31/25. PRC is scheduled 8/13/25 7/1/25: RaPID scheduled 7/8/25, PRC is scheduled for 8/13/25. 6/2/25: 1st draft of protocol has been circulated, scheduling RAPID *end of June-Early July. 5/5/25: Concept was approved by CTEP. 4/29/25: Concept was resubmitted. 4/25/25: Call with CTEP occurred, reviewers were pleased with PI responses to their comments and asked for concept to resubmitted. 3/18/25: Concept Review comments "The Committee was supportive of the proposed trial; however, before this concept can be approved, the following major comments will need to be addressed and submitted with a Revised Concept. " Call with CTEP to discuss comments is scheduled for 4/7/25. 3/4/25: Concept was submitted to CTEP 2/12/25 2/4/25: Pending executive officer approval to submit concept to CTEP 11/6/24: Triage approved capsule S2310: 7/25/24: Call with CTEP to discuss disapproval letter, SC provided responses to disapproval 6/10/24: Received concept disapproval 3/29/24: concept was submitted to CTEP for review. 1/29/24: Triage approved |
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| Gastrointestinal Cancer | ||
| S2605 Preoperative Chemotherapy versus Surgery First (CRS-HIPEC) for High Grade Appendiceal Carcinoma. |
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Capsule Summary Approval Date: 09/24/2025
Concept or Lol submit to NCI: 12/16/2025 Target Date: 10/23/2026 Drop Dead Date: 07/20/2027
Progress:
135
of 270 days
Current Status: *10/17/2025: Triage Approval Letter received and SWOG study ID assigned (S2605). 10/22/2025: Met with Dr. Unger and Dr. Jones to review PRO-related feedback from the Triage Committee and outline revisions to strengthen the concept and address feasibility considerations. 10/24/2025: Held the first Study Team Kickoff Call to discuss proposed concept updates, confirm development priorities, and establish a preliminary timeline for Steering Committee submission. Week of 11/3/2025: Refining concept documents based on feedback and preparing the SAWS worksheet. Week of 11/17/2025 (Target): Planning to hold the F&F call; currently confirming availability with stakeholders 11/21/2025: F&F Call - notes and updated concept circulated on 11/24/25. 12/15/2025: submission to GISC 01/26/2026: NCI GI Steering Committee Review 2/10/2026: Received Outcome Letter - Pending Status [A major concern was the weakness of the supporting data in that the datasets were relatively small and entirely observational, raising the probability of substantial bias as the reason for the noted outcome differences between the two sequences.] 2/24/2026: Meeting with GI Steering Committee to review comments 3/2/2026: Concept resubmitted to PIO 3/16/2026: Final review of Concept. 04/06/2026: Received Approval letter from NCI - Will circulate an email to all stakeholders on 4/7, begin scheduling study team calls, and start developing the first draft of the protocol. 04/13 /2026: Protocol and Consent Draft 1 sent to study team 04/23/2026: Kick Off Study Team Call 05/01/2026: SWOG Group Meeting 05/20/2026: Consent sent to Patient Advocate and Plain Language Writer 06/01/2026: RaPID Prep Meeting. 06/12/2026: RaPID. Currently being rescheduled to allow additional protocol development and study chair input. The study team continues to meet weekly and recently held an extended working session to further develop Section 07 of the protocol. 07/08/2026: Stats PRC TARGET SUBMISSION: July 31, 2026 |
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| S2615 A Randomized Phase 2/3 Trial of Amivantamab + mFOLFOX or Amivantamab Alone vs. mFOLFOX Alone for Pretreated KRAS Wild-Type Biliary Tract Cancer |
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Capsule Summary Approval Date: 05/06/2026
Current Status: 04/10/2025: HB Task Force Review. 06/18/2025: Statistical Protocol Review Committee (PRC) Review. 06/30/2025: Patient Advocate Meeting. 07/25/2025: Call with CTEP. 08/22/2025: Updated study design circulated based on stakeholder feedback and discussions with CTEP. 01/2026: Janssen reviewed updated concept and approved to move forward. (Received confirmation in late Feb. 2026) 04/06/2026: Submitted to SWOG Executive Committee. 04/13/2026: SWOG Executive Committee Review. 05/06/2026: Received SWOG Approval Letter. 05/21/2026: Submitted to Hepatobiliary Task Force for review of the revised primary endpoint and updated study design. 06/11/2026: Hepatobiliary Task Force Review. The concept is returning to Task Force for re-review, as the previous review occurred over one year ago. Progress on the study was delayed due to the federal government shutdown. Since that time, discussions between the CTEP Drug Officer and Janssen have occurred, and both parties have confirmed their support for moving the trial forward. 06/2026: Feasibility and Funding (F&F) Call currently being scheduled. 07/20/2026: Planned submission to GI Steering Committee. |
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| Genitourinary Cancer | ||
| S2611 A Randomized Comparison of Intravesical TherapieS (ARCIS): A randomized phase III study of intravesical gemcitabine and docetaxel (GEM-DOCE) versus intravesical cretostimogene grenadenorepvec and gemcitabine (CRETO-GEM) for the treatment of bacille Calmette-Guerin (BCG)-unresponsive and BCG-exposed non-muscle invasive bladder cancer (NMIBC) |
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Capsule Summary Approval Date: 11/18/2025
Concept or Lol submit to NCI: 04/22/2026 Target Date: 02/14/2027 Drop Dead Date: 11/11/2027
Progress:
21
of 270 days
Current Status: 11/18/25: Triage Approved 11/24/25: Risk assessment completed - communicate proactively w/new company (CG Oncology) 12/2/25: F&F call scheduled for 12/16 (calendar invite will be sent 12/2). GUSC review for January - deadline to submit is 12/24 1/6/26: Concept and LOS submitted on 12/17 for GUSC review on 1/21. Scheduling slides review/anticipated GUSC questions review for study team. 2/3/26: GUSC reviewed on 1/21, awaiting decision. 2/12/26: Concept withdrawn from GUSC. New study number: S2611. Plan to resubmit to GUSC after CORE-008 data is released and incorporated into concept (submit by 4/22 for 5/20 review). Dr. Agarwal (GU EO) will present brief study updates to SWOG triage on 3/9. 6/2/26: Concept presented to GUSC on May 20, pending decision. |
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| S2613 Assessing the need for Pelvic Lymphadenectomy at the time of Prostatectomy for Prostate Cancer with PSMA-PET based Evaluation: A Multicenter, Randomized Phase III Clinical Trial |
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Capsule Summary Approval Date: 03/12/2026
Concept or Lol submit to NCI: 05/20/2026 Target Date: 03/14/2027 Drop Dead Date: 12/09/2027
Progress:
-7
of 270 days
Current Status: Triage approved 3/12/26. Risk assessment complete. F&F scheduled for 4/23. Internal study team kickoff call currently being scheduled. IROC kickoff call will occur before GUSC submission. GUSC submission planned for May 20 (June 17 review date). GUSC confirmed review date of 6/17. Study team will meet 6/11 to review slides and GUSC questions prior to presenting. Plan to use discretionary funding for IROC blinded real-time central review for now, BIQ still an option. |
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| Leukemia | ||
| S2507 A Phase II Randomized Study of Blinatumomab with or without Revumenib for Patients with KMT2A Translocation B-Cell Acute Lymphoblastic Leukemia (ALL)/ Acute Leukemia With Ambiguous Lineage (ALAL) with Persistent Measurable Residual Disease (MRD) |
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Capsule Summary Approval Date: 04/22/2024
Concept or Lol submit to NCI: 02/04/2025 Target Date: 10/19/2025 Drop Dead Date: 10/14/2026
Progress:
414
of 180 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. 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. 10/10/2024: LOI reviewed by PRC. 10/29/2024: CTEP Review on Hold pending response to comments and NCI conference call. 11/12/2024: NCI teleconference call occurred. 11/20/2024: LOI Withdrawn from CTEP. 01/03/2025: Re-design finalized. 01/27/2025: Presented at Triage by Dr. O'Brien as an FYI. Reassigned new study number S2507. 02/04/2025: Concept submitted to LKSC. 03/25/2025: Pending new LKSC review date. 05/02/2025: LKSC approval received. 05/19/2025: Initial protocol draft circulated to study team. 06/30/2025: RaPID call scheduled. 07/30/2025: Stats PRC occurred. 08/05/2025: Aiming to submit to CTEP beginning of September. 09/05/2025: Protocol submitted to CTEP. 10/23/2025: FDA comments received. 11/07/2025: Responses to FDA comments submitted. 11/13/2025: FDA placed a partial clinical hold on the study. 11/17/2025: Responses to FDA hold comment submitted. 11/24/2025: Responses to FDA non-hold comments submitted. 11/24/2025: Meeting with Syndax to discuss trial funding and support. 12/17/2025: FDA approval to proceed received, removal of partial clinical hold. 12/29/2025: CTEP Consensus Review received. 01/30/2026: Consensus Review responses submitted to CTEP. 03/24/2026: 2nd Consensus Review received. Pending resubmission of study team responses. 04/07/2026: 2nd Consensus Review responses submitted. 04/28/2026: CTEP AOH received. 05/27/2026: CIRB consensus review received - responses due 6/10. |
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| S2603 A Phase II Study of Nuvisertib and Decitabine-Cedazuridine for Myelodysplastic/myeloproliferative neoplasms (MDS/MPNs) |
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Capsule Summary Approval Date: 08/18/2025
Concept or Lol submit to NCI: 02/25/2025 Target Date: 07/26/2026 Drop Dead Date: 07/21/2027
Progress:
134
of 180 days
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. 12/11/2024: Concept finalized. 01/24/2025: Sumitomo letter of support obtained. Feedback on Concept received and responses sent. 02/25/2025: Submitted to LKSC; may be reviewed by PRC. 03/13/2025: Scheduled for PRC Review. 03/17/2025: Disapproved by CTEP. 05/06/2025: Call with NCI for disapproval comments. 05/15/2025: Study redesign in progress. 08/18/2025: Reviewed at Triage as an FYI and assigned a new study number S2603 (formerly S2502). 09/23/2025: mini-F&F call. 10/21/2025: Concept submitted to CTEP. 01/27/2026: LKSC review. 02/19/2026: Handover meeting with Andrea. 02/26/2026: LKSC Consensus Evaluation Received. 03/10/2026: Resubmission of the updated Concept to LKSC. 03/16/2026: Updated Concept presented as FYI at Triage. 04/28/2026: Scheduled date of LKSC re-evaluation of Concept. 05/22/2026: LKSC approval to begin protocol development. |
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| Lung Cancer | ||
| S2608 Sequencing of IMmunOtherapy and chemoradiotherapy in unresectable stage III Non-small cell lung cancer (SIMON): A Randomized Phase III Study |
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Capsule Summary Approval Date:
Current Status: 6/10/25 - Feasibility & Finance Call 5/21/26 - TMSC Re-review 2/26/26 - TMSC Review 1/7/26 - CTEP submission for TMSC review on 2/26/26 1/5/26 - Triage approval 12/22/25 - Triage FYI review 12/9/25 - Stats PRC review 7/26/25 - We are waiting to hear who will lead the study, SWOG or ECOG. 6/15/25 - Dr. Zhao drafted a revised Phase II/III Concept design that does not pause the study. SWOG wants to know who will run the study, if it will be SWOG or another cooperative group, before additional effort is used on this study. 6/3/25 - Study team met with CTEP on 5/22/25 to discuss the Consensus Review comments for the Concept. CTEP prefers the study use durva and they are flexible on Phase II/III for PFS go/no-go as long as there is no break in accrual or a Phase III study. Stats is reviewing different design options. Additional discussions with CTEP, Stats, and AZ will take place before a final design is determined. 5/5/25 - Coordinating follow-up call with CTEP, SWOG, and AZ to discuss revised Phase III Registrational Concept 4/25/25 - Study team call with AZ to propose a revised Phase III Registrational Concept 4/7/25 - Concept Disapproval 4/1/25 - Risk Assessment 3/20/25 - TMSC Review Meeting (outcome of review anticipated by mid-April) 2/13/25 - Submitted concept to PIO for TMSC review. 2/10/25 - Triage review and approval. Rushed to Triage since ECOG submitted a similar concept to TMSC. Previously S2509. TMSC review on 2/26/26. TMSC re review on 5/21/26. |
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| S2612 A phase II study of atezolizumab and JBI-802 for previously treated extensive stage small cell lung cancer (SCLC) |
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Capsule Summary Approval Date: 03/16/2026
Concept or Lol submit to NCI: 03/27/2026
Current Status: 5/26/26: LOI Resubmission with Responses to NCI 4/21/26: NCI had questions for study team 4/16/26: NCI PRC Review 3/27/26: LOI Submitted to CTEP 3/16/26: FYI Triage Review and Approval 8/6/25: TMSC Disapproval 7/17/25: TMSC Review 5/28/25: Concept submitted to CTEP. CTEP requested the addition of a references section, which has now been included. Resubmitted on 6/3 4/28/25: Sent updated concept to Jubilant and GNE to confirm they are still agreement to move study forward 1/31/25: Sent study team the updated Version 4.3 concept form for them to fill out and review 1/17/25: Internal meeting to discuss next steps 11/8/24: Meeting with Jubilant and Dr. Starodub, who shared insights on his experience with the drug and protocol. 8/26/24: Exec. Cmte/ Triage Approved Formally, S2503 and S2410. Concept was initially disapproved by CTEP due to drug company support withdrawal. TMSC reviewed updated S2503 concept and did not approve due to insufficient differentiation from prior LSD1 ICI data and a shifting therapeutic landscape. Now the current design differs from S2503 in that it is single arm design (instead of randomized) with a smaller sample size. The drug is still LSD1+HDAC6 inhibitor. |
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| LungMAP | ||
| S1900N A Randomized Phase II Study of Sacituzumab Govitecan alone, Ivonescimab alone, or Sacituzumab Govitecan and 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
Concept or Lol submit to NCI: 01/24/2025 Target Date: 08/12/2025 Drop Dead Date: 08/07/2026
Progress:
482
of 180 days
Current Status: Absolute Deadline: 8/7/2026 6/1/2026 - Awaiting contract execution with Gilead and Summit, Gilead is finalized. DTL approved 6/1. Funding Sheet approved 5/19. 4/7/2026 - Awaiting contract execution with both Gilead and Summit. 3/3/2026 - CIRB Approval on 2/28/2026. CIRB Approval pending modification on 2/11/2026. Letter revised on 2/18/2026. Re-submitted on 2/24/2026. 2/3/2026 - CIRB review expected to occur on 2/5. 1/6/2026 - CTEP approval on hold for CIRB review received 1/5 after submission on 12/23. Absolute deadline extended from 5/9 to 8/7/2026. 12/2/2025 - CTEP Review comments received 11/25. Pharma sent edits on 12/1 for their review by 12/10. 11/4/2025 - Re-submission occurred 10/17, outside of FDA review window, but recalled 10/20 due to needed edit. Submitted to CTEP on 10/24. Anticipated activation date changed to 2/1/26 from 12/1/25 due to government shutdown. 10/6/2025 - Re-submitted to CTEP on 9/9. Comments received on 9/24. ST made updates and sent to pharma for review on 9/26. Review is pending, was expected 10/3. 8/29/2025 - NCI call occurred on 8/14. ST made updates by 8/25. Ops sent to pharma for review on 8/26. 8/5/2025 - Consensus Review received 7/30. Study Team met to discuss on 7/31. NCI call to review comments scheduled for 8/14. 6/30/2025 - Initial Protocol CTEP Review submitted on 6/26. 6/2/2025 - Stats PRC held on 5/21. Review comments pending. SCC reviews received 5/29. 5/6/2025 - Stats PRC planned 5/21. Nationwide/FMI review expected 5/6. 3/31/2025 - RaPID call scheduled for 4/4. 3/21/2025 - CTEP Approval with Stipulations given 3/21. 3/4/2025 - NCI call held on 3/3 to discuss protocol stipulations. Protocol development underway. First draft to study team expected by 3/7. 2/25/2025 - Concept Approval On-Hold given from CTEP on 2/25. 2/13/2025 - CTEP consensus review held on 2/13. 1/29/2025 - F&F held on 1/22. Stats PRC held on 1/15. Concept submitted to CTEP on 1/24. Protocol development starting while concept review pending. 1/6/2025 - Met with collaborators on 12/19. NCI Pre-Look meeting held on 12/23. Call with collaborators planned for 1/9. Stats PRC scheduled for 1/15. F&F scheduling in progress. Official concept submission goal of 1/24. 12/2/2024 - 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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| S1900P A Randomized Phase II Selection Design of Sapanisertib and Paclitaxel with or without Serabelisib in Participants with NFE2L2, KEAP1 or PI3K Pathway-Positive Stage IV or Recurrent Squamous Cell Lung Cancer (ECOG-ACRIN Lung-MAP Sub-Study) |
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Capsule Summary Approval Date: 06/06/2025
Current Status: 6/1/26 - Feedback on the revised concept has been received from Faeth. The study team is reviewing their comments. The next meeting with Faeth is scheduled for 6/9/26. 5/6/26 - Faeth's feedback was originally due to the study team on 5/6/26. They requested additional time to review. 4/21/26 - Revised concept sent to Faeth 4/7/26 - Study team met with Faeth on 3/24/26 to discuss update to the study design. The study team is revising the concept and will send it to Faeth to review. 3/13/26 - Study team met with CTEP to discuss the pre-look comments. 3/9/26 - CTEP call to discuss pre-look comments was rescheduled due to the availability of key participants. 3/3/26 - Study team is addressing CTEP's feedback. Call with CTEP on 3/9/26 to discuss comments. 2/20/26 - CTEP pre-look comments received. 2/3/26 - CTEP indicated the pre-look will be reviewed this week. Comments anticipated by 2/13/26. 1/26/26 - Bypassing a Feasibility & Finance (F&F) Call. SAW sent to SWOG budgets/contracts/legal teams for review. Risk Assessment in progress. 1/13/26 - Concept submitted to CTEP for pre-look 1/12/26 - Study team responded to Faeth's feedback. Faeth provided approval to move forward with CTEP pre-look submission. 1/8/26 - Draft concept feedback received from Faeth. 1/6/26 - Faeth's feedback was originally due 12/17/25, but they have requested an extension and their feedback is now due 1/7/26. Once Faeth and Lung-MAP finalize the concept it will be submitted to CTEP for a pre-look. 12/1/25 - Draft concept sent to Faeth for review. Faeth's feedback is due 12/17/25. 11/21/25 - Company Kick-Off Call 11/4/25 - The study team is incorporating minor edits into the stats section of the concept. The document is expected to be finalized soon. Faeth will be given the opportunity to review prior to pre-look submission. CTEP will not review new concepts until the government shutdown ends. 10/6/25 - Internal Kick-Off Call 9/25/25 - Study Chair, Co-Chair, Champion confirmed their willingness to participate 9/23/25 - Study Chair, Co-Chair, Champion invitations sent 9/19/25 - Study team met with Faeth to discuss the budget and study design options. Faeth confirmed their willingness to support concept and protocol development. 9/7/25 - FNIH sent a high-level budget proposal to Faeth 8/11/25 - Study team and FNIH sent draft concept and budget estimate to Faeth 8/4/25 - Study team sent initial concept draft to FNIH and SWOG for the budget estimate to be drafted 6/6/25 - DSC Approved. DSC Approval Letter sent to Faeth. Faeth asked to review draft budget and design options before committing to move forward with study development. Anticipated activation Q4 2026/Q1 2027 |
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| S1900Q A Phase II Study of Zongertinib with Trastuzumab Deruxtecan in HER2 Dysregulated Relapsed/Refractory Advanced Non-Small Cell Lung Cancer (Alliance Lung-MAP Sub-Study) |
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Capsule Summary Approval Date: 10/03/2025
Current Status: 6/1/2026 - Concept was updated and Stats PRC held 5/27. Awaiting stats comments. 4/7/2026 - Pre-Look submitted on 3/10 after additional changes. Pre-Look comments returned 4/6. Study Team discussing CTEP comments requiring design changes. 3/3/2026 - Pre-Look submission made 2/27/2026 but withdrawn same day to make edits. Pre-Look submission expected by 3/4/2026. 2/3/2026 - Study Team made edits to concept. Given to BI for review on 2/2 ahead of pre-look submission. Review expected by 2/16. 1/6/26 - Dr. Redman is drafting the study design for the concept. The Company Kick-Off Call is scheduled for 1/23/26. 12/10/25 - Initial BI portal submission completed. The study team is actively discussing key elements of the study design and gathering data necessary to make informed decisions regarding accrual, accrual rate, interim analyses, and related operational considerations. These factors will directly inform the overall budget. 11/24/25 - Statistical design is being drafted. The accrual total is needed to generate a high level budget estimate for the BI portal. 11/14/25 - Internal call to discuss the study design 11/7/25 - Internal Kick-Off Call 10/31/25 - Study team met with Boehringer Ingelheim to discuss portal usage 10/29/25 - Study Chair, Co-Chair, Champion invitations sent and all confirmed their willingness to participate. The study team confirmed they are working on the concept. 10/27/25 - Boehringer Ingelheim confirmed their willingness to support concept and protocol development 10/4/25 - DSC approval letter sent to Boehringer Ingelheim 10/3/25 - DSC Approved Anticipated activation Q4 2026/Q1 2027 |
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| Lymphoma | ||
| S2506 MOZART MZL: A Randomized Phase II Study with a Common Control Arm of Mosunetuzumab Monotherapy Evaluated Against Two Experimental Treatment Arms of Either Combination Mosunetuzumab and Zanubrutinib or Mosunetuzumab and Polatuzumab Vedotin for the Treatment of Patients with Relapsed/Refractory Marginal Zone Lymphoma |
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Capsule Summary Approval Date: 12/23/2024
Concept or Lol submit to NCI: 02/14/2025 Target Date: 10/08/2025 Drop Dead Date: 10/03/2026
Progress:
425
of 180 days
Current Status: 6/2/26: Received AOH from CTEP on 5/18/26. The IR application will be reviewed by CIRB on 6/4/26. Due to multiple rounds of review comments from CTEP, target activation has been updated to 8/1/26. 4/2/26: The revised protocol was resubmitted to CTEP. Target activation has been updated to 6/1. 3/24/26: Additional CTEP consensus review comments received. 3/11/26: FDA Study May Proceed letter received. 3/3/26: The FDA requested additional information. That information was provided on 2/25/26. Pending updates from CTEP regarding the revised protocol. 2/9/26: IND was submitted to the FDA. 2/6/26: The revised protocol was submitted to CTEP. 2/3/26: Anticipated resubmission to CTEP 2/5. Target activation updated to 5/1/26. 1/9/26: BeOne LOA received. Plan is to submit the version of the protocol resubmitted to CTEP to the FDA. 1/8/26: Consensus review comments received. 1/6/26: Working with both BeOne and GNE on additional protocol edits. BeOne to provide cross-reference letter as soon as possible after protocol approval. Pending CTEP consensus review comments. 12/9/25: OWEG drop dead date adjusted to 10/3/2026. Target activation now 3/16/26. 11/7/25: Protocol submitted to CTEP. Pending cross-reference letter from BeOne for FDA submission. 11/4/25: Had touchbase calls with BeOne (10/20) and GNE (11/3). Anticipated submission to CTEP this week. 10/7/25: Received approval from GNE and BeOne. Finalizing protocol for submission to CTEP. 8/20/25: Stats PRC 8/1/25: RaPID call. Stats PRC scheduled for 8/20. 7/21/25: Meeting with BeOne to discuss updated budget. BeOne will forward updated budget to internal review for approval; unsure when to expect a response, but is also much more comfortable with udpates. 7/18/25: Meeting with GNE to discuss updated budget. GNE more comfortable with new budget, will submit to internal review committee for approval. GNE anticipates providing a response to their review by end of August/early September. 7/10/25: Internal study team meeting to discuss budget items. Both pharma partners expressed concern about proposed budget. The study team has agreed to reduce the number of PROs administered from 3 to 1 and to reduce the number of timepoints from 5 to 3. Revised budgets submitted to pharma partners. July 2025: RaPID to be rescheduled due to scheduling conflicts 5/19/2025: Internal KOC; study team responses submitted to CTEP 5/12/2025: Study team call with CTEP 4/22/2025: Concept approved by CTEP 4/11/2025: Concept to be reviewed by steering committee 2/14/2025: Concept submitted 1/20/2025: Risk Assessment: 12/23/2024: Triage approved |
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| Melanoma | ||
| S2601 Multicenter Selective Lymphadenectomy Trial III: A randomized phase 3 , International, Multicentre, Randomised, Controlled Trial of Selective Index Lymph Node Resection versus Therapeutic Lymph Node Dissection after Neoadjuvant Immunotherapy for Stage IIIB-D Melanoma |
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Capsule Summary Approval Date: 07/17/2025
Concept or Lol submit to NCI: 10/30/2025 Target Date: 10/20/2026 Drop Dead Date: 10/15/2027
Progress:
138
of 270 days
Current Status: 3/16/26: Had call with NCI. Study team plans to submit response to NCI comments this week. Scheduling a min F & F call. 2/20/26: NCI provided comments on concept with a pending vote for the concept. Study team has call with NCI scheduled for 3/9/26 to discuss comments. We have a draft response ready for submission. 2/3/2026: Pending CTEP decision on concept, on 1/23/2026 Pi presented at MSCSC Meeting, and responded to reviewers comments. 1/6/2026: no updates, pending CTEP review scheduled 1/23/2026. 12/2/2025: Concept is scheduled to be reviewed by CTEP 1/23/2026. 11/4/2025: Concept was submitted to CTEP 10/30/2025. 10/6/2025: Finalizing concept and MIA supporting documents (letter of commitment and NCI Questions for New International Organizations) for CTEP submission. 9/2/2025: F & F is scheduled for 9/5/2025. 7/17/2025: Concept Triage approved |
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| S2616 A randomized phase 3 study of pembrolizumab vs. standard of care observation in patients with subclinical Merkel Cell Carcinoma and positive ctDNA after surgery or radiotherapy |
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Capsule Summary Approval Date: 05/04/2026
Current Status: 5/4/2026: Triage approved concept |
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| S2617 Neo-PRIME: Phase III Trial of Botensilimab and Pembrolizumab in Resectable Melanoma |
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Capsule Summary Approval Date: 04/28/2026
Current Status: 6/1/2026 - Study Team met for Internal Kick Off Call on 5/12 to discuss edits. Risk Assessment to occur 6/2 and F&F to occur 6/4. CTEP submission deadline 6/26 for 7/25 review is the expected submission date of the updated concept. 4/28/2026 - Triage Approval with comments. |
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| Myeloma | ||
| S2508 Phase II Study of Induction Therapy plus or minus Teclistamab for Participants with Newly Diagnosed High-Risk Multiple Myeloma (HRMM) |
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Capsule Summary Approval Date: 02/25/2025
Concept or Lol submit to NCI: 06/30/2025 Target Date: 11/24/2025 Drop Dead Date: 11/19/2026
Progress:
328
of 130 days
Current Status: 02/25/2025: Capsule approved by Triage. 02/25/2025: Internal Study Team Kick off call scheduling pending. 03/19/2025: Internal Study Team Kick off call. 04/21/2025: Internal SWOG NOC and Janssen call to discuss TM funding. 05/12/2025: F&F Call scheduled. 05/28/2025: LOI finalized. 06/17/2025: JNJ determination to support the TM outside of CRADA. 06/30/2025: LOI submitted to PIO. 07/30/2025: PRC comments received, must be re-submitted, 08/13/2025. 08/29/2025: Requested submission extension, LOI re-submitted 08/29/2025. 10/03/2025: Review on Hold received; pending 10/14 resubmission of revised LOI. 10/14/2025: LOI resubmitted to CTEP. 12/15/2025: LOI received CTEP Approval On Hold. Full Approval will be issued once the Drug Commitment Letter is received from Janssen. 01/06/2026: The first draft of the protocol is being written. RaPID is scheduled for 03/25/26. 01/07/2026: Janssen submitted signed Drug Commitment Letter to PIO/CTEP 01/13/2026: LOI Received CTEP Full Approval 02/03/2026 - Study team is working on the protocol. Stats PRC is scheduled for 04/15/26. 03/03/2026 - Study team is working on the protocol in preparation for RaPID on 03/25/26. Stats PRC is scheduled for 04/15/26. Target initial submission of the protocol to CTEP 05/20/26. 03/25/2026 - RaPID 03/31/2026 - Informed Consent Review Call 04/07/2026 - The study team is updating the post-RaPID draft of the protocol and ICF in preparation for Stats PRC on 04/15/26. Target initial submission of the protocol to CTEP 05/20/26. 05/18/26 - Protocol submitted to CTEP for initial review. CTEP Consensus Review comments anticipated in mid-June. 09/01/2026: Target Activation |
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| myeloMATCH | ||
| MM1-S06 MM1-S06, A Phase 2 Study of Novel Agents with Venetoclax and the DNMT1 Inhibitor Cedazuridine-Decitabine for Newly Diagnosed Acute Myeloid Leukemia/Myelodysplastic Syndromes with TP53 Mutations (NAVIGATE-TP53): A MyeloMATCH Substudy |
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Capsule Summary Approval Date: 12/01/2025
Current Status: Re-review at Senior Science Council 5/26/26. Risk Assessment pending. Approved by triage 12/1/25. Reviewed by triage 11/24/25. |
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| MM1OA-S04 A Phase 2 trial of ASTX727 with standard duration versus shorter duration of venetoclax in genomically heterogenous AML among adults aged 60 or older and less fit for intensive therapy: a myeloMATCH substudy. |
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Capsule Summary Approval Date: 03/10/2025
Concept or Lol submit to NCI: 03/24/2025 Target Date: 01/17/2026 Drop Dead Date: 10/14/2026
Progress:
414
of 270 days
Current Status: Pre-Activation Submission to CTEP 5/7/26. CTEP approval on hold 5/6/26. CIRB approval 3/26/26. FDA Consensus Review received 3/24/26. 2nd Submission to CIRB 3/20/26. CIRB meeting planned for 3/5/26. Submitted to CIRB 2/12/26. 3rd Submission to CTEP 1/9/26. 2nd Consensus Review received 12/30/25. 2nd Submission to CTEP 11/19/25. 2nd NCI OEWG Teleconference 11/18/25. Consensus Review received 09/10/25. Submitted to CTEP 8/19/25. Concept Approved 8/5/25. PRC review 7/16/25. RaPID Call 6/24/25. NCI OEWG Teleconference 5/29/25. Internal Kick Off 5/20/25. LKSC approval "on hold" pending drug commitment 5/1/25. F&F Call 4/24/25. LKSC reviewed 4/22/25. Concept submitted to CTEP 3/24/25. Risk Assessment (email) 3/21/25. Reviewed and approved by triage 3/10/25. |
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| MM1OA-S05 A RAS-Activated Biomarker Driven Phase II Study Evaluating Addition of Tuspetinib to CPX-351 Induction Therapy in Older Fit Adults with Acute Myeloid Leukemia: A myeloMATCH Substudy |
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Capsule Summary Approval Date: 06/12/2025
Concept or Lol submit to NCI: 07/24/2025 Target Date: 05/23/2026 Drop Dead Date: 02/17/2027
Progress:
288
of 270 days
Current Status: Submissed to CTEP 6/1/26. PRC review 4/22/26. RaPID Call 3/30/26. Concept Approved 2/12/26. NCI OEWG Teleconference 11/25/25. Approval On-Hold 09/16/25. LKSC review 8/26/25. Concept submitted to CTEP 7/24/25. F&F Call 7/11/25. Risk Assessment (email) 6/26/25. Reviewed and approved by triage 6/9/25. |
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| Palliative Care | ||
| S2415 Acupuncture to Decrease Symptom Burden in Patients with Metastatic Breast Cancer |
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Capsule Summary Approval Date: 09/11/2023
Concept or Lol submit to NCI: 06/24/2024
Current Status: 06/01/2026: The study team received an update from program leadership indicating that discussions are ongoing with NCCIH regarding potential co-funding opportunities. A funding decision is not expected prior to the NCI Council meeting at the end of June. Based on discussions with the Program Officer, the team will defer any resubmission plans until the current funding cycle has concluded. If funding is not secured this fiscal year, the team will evaluate resubmission during the November 2026 cycle. 3/15/2026 - First-round reviews for the R01 resubmission are in and scored well (impact score 25, percentile 12), appearing to be in a fundable range this cycle. Overall feedback was positive, with only minor questions around endpoints and feasibility—nothing that seemed to significantly impact enthusiasm. We’ll look to DCP for guidance on next steps. 10/15/2025 - R01 Re submission 9/26/25 - Pitch the PAC review of concept 7/25/25- Submission not funded. Will discuss re-submission next cycle. 10/17/24: R01 was reviewed (Score 31, Percentile: 15.0) 6/4/24: R01 Re submission 10/5/23: R01 Submission 9/11/23: Triage as FYI 8/16/23: Stats PRC |
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| Prevention, Screening, and Surveillance | ||
| S2614 A Multicenter, Double-Blind, Placebo-Controlled Randomized Phase III Trial of Finasteride to Prevent Recurrence in Patients with Low-Grade Intermediate-Risk Non-muscle Invasive Bladder Cancer (IR-NMIBC) |
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Capsule Summary Approval Date: 01/05/2026
Current Status: 6/5/26: Practice run of SC presentation to be held on Friday, June 5th at 4:00 p.m. CT. 5/31/26: Dr. Psutka distributed slides for SC presentation and asked for comments. 4/15/26: Concept renumbered and resubmitted for DCP SC review on June 9, 2026. 4/7/26: Concept withdrawn in order be on the Steering Committee June agenda. 4/2/26: Concept submitted.Reboot Rx hired a consultant to help weigh options for procurement of finasteride and placebo. There are 2 paths being explored. 3/2/26: Reboot Rx announced that their philanthropist approved support for this study. 2/19/26: Reboot Rx is meeting with Hetero (generic manufacturer of finasteride) to discuss possibility of drug supply for this study. |
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| SWOG CTP | ||
| 21CTP.BREAST01 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: 02/12/2025
Concept or Lol submit to NCI: 12/24/2024 Target Date: 08/04/2025 Drop Dead Date: 05/01/2026
Progress:
490
of 180 days
Current Status: 06/02/2026: Final protocol edits addressing the NCA discrepancies were approved by the collaborating companies on 05/28. The study timeline, budget and FMV assessment are currently being updated ahead of ERC resubmission followed by WCG IRB submission. 04/07/2026: Resubmission to the CTP ERC was completed on 03/20, with an approval-on-hold status received on 03/31. Currently addressing NCA and other budget items with collaborating companies. Note that the FDA and WCG IRB submissions are contingent on the execution of the main study contracts. 03/03/2026: Resubmission to CTP ERC is currently delayed as we await the final reviews and sign-offs from the pharma companies on the revised protocol draft. 02/03/2026: Resubmission to CTP ERC is currently delayed as we await the final reviews and sign-offs from the pharma companies on the revised protocol draft. 01/06/2026: Resubmission to CTP ERC is currently delayed as we await the final reviews and sign-offs from the pharma companies on the revised protocol draft. 12/02/2025: Resubmission to CTP ERC is currently delayed as we await the final reviews and sign-offs from the pharma companies on the revised protocol draft. 11/04/2025: Resubmission to CTP ERC is currently delayed as we await the final reviews and sign-offs from the pharma companies on the revised protocol draft. We are also pending review feedback on the NCA that was submitted for review on 10/24. 10/06/2025: CTP ERC Review held on 09/16. ERC comments were received on 10/02. The study team is currently addressing the ERC comments, along with FDA and pharma comments. 09/03/2025: Stats PRC scheduled. 08/06/2025: RaPID call occurred. 07/01/2025: Start up agreement executed 6/16. Study Team working on first drafts of protocol and consent. 06/03/2025: CTP ERC has approved concept, and pending startup agreement execution. 05/06/2025: CTP ERC has approved concept, and pending startup agreement execution. 04/01/2025: CTP ERC has approved concept, and pending startup agreement execution. 03/04/2025: CTP ERC has approved concept, and pending startup agreement execution. 02/04/2025: Study Team is working on the updated CTP ERC responses. 01/07/2025: Submitted the responses to the CTP ERC on 12/12/24. 12/03/2024: The study team is working on CTP ERC responses. 11/01/2024: The study team is working on CTP ERC responses. 10/01/2024: Received CTP ERC Capsule Outcome Review Letter on 09/23/24. The study team is working on responses. 09/03/2024: CTP ERC reviewed the concept on 8/20, pending ERC review letter. 08/06/2024: The capsule will be presented to CTP ERC on 8/20 for their review. 07/01/2024: The updated capsule and budget have been submitted to AZ. The study team is pending approval of the capsule/budget and ERC approval. 06/04/2024: The updated capsule and budget have been submitted to AZ. The study team is pending approval of the capsule/budget and ERC approval. 05/07/2024: 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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| 26CTP.LEUK02 APEX-MF, A Randomized Trial Comparing Momelotinib vs Dose-Adjusted Ruxolitinib for Treatment-Naive, Cytopenic Myelofibrosis |
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Capsule Summary Approval Date: 09/23/2025
Concept or Lol submit to NCI: 09/16/2025 Target Date: 06/20/2026 Drop Dead Date: 03/17/2027
Progress:
260
of 270 days
Current Status: 05/27/2026: Study submitted to WCG IRB for review. 04/29/2026: Main contract executed with GSK. 03/13/2026: GSK granted approval of protocol documents. 03/12/2026: SWOG ERC granted Approval on Hold. 03/06/2026: Protocol and ICD resubmitted for SWOG ERC and GSK review. 03/02/2026: ERC response letter received with comments from SWOG ERC. 03/02/2026: Study Team responses submitted to GSK. 02/27/2026: GSK response received with comments. 02/20/2026: Protocol and ICD resubmitted for SWOG ERC and GSK review. 02/04/2026: ERC response letter received with comments from SWOG ERC and GSK. 01/16/2026: Protocol and ICD submitted for SWOG ERC and GSK review. 12/17/2025: Stats PRC occurred. 11/19/2025: ICD review occurred. 11/12/2025: RaPID call occurred. 10/31/2025: SWOG CTP ERC approval received. 10/27/2025: First draft of consent sent to study team. 10/17/2025: Study Team responses submitted to ERC. 10/14/2025: Protocol RaPID scheduled. 10/13/2025: First draft of protocol sent to study team. 10/03/2025: ERC letter circulated and start-up agreement executed. Protocol development underway. 09/23/2025: Underwent SWOG CTP ERC review, received approval with responses required. |
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| Symptom Management and Survivorship | ||
| 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 RE-SUBMISSION for July 2025** 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. 11/22/24: Received an impact score of 34, 19th percentile. Waiting on summary statement before resubmission. 01/08/25: Summary statements received. Planned resubmission for July 2025. 01/21/25: Study team call to re-group. Targeting aims submission to DCP beginning of March and 7/5/25 resubmission for R01. 04/01/25: No new updates. Still planning on 7/5/25 resubmission for R01. 06/03/25: Received NCI DCP approval to resubmit R01 in July. 07/01/25: R01 currently on-track for resubmission by 7/7 (7/5 is a Saturday). 07/02/2025: R01 was resubmitted. 11/4/2025: R01 still under review, no updates (gov't shutdown). 11/21/25: R01 will be reviewed on 1/16/26. 1/6/2026: R01 will be reviewed on 1/16/26. 2/3/2026: R01 not discussed at the review meeting (categorized as "competitive - not discussed"). Awaiting summary statement as of 1/21. 2/16/2026: Dr. Sun asked DCP if they can resubmit the concept again as a new R01 submission. 3/30/2026: Study Team decided to revisit the population and will resubmit R01 in October. |
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