Protocol Tracking Reports: Dashboard
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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:
298
of 180 days
Current Status: 9/1/26: Drug commitment from Novartis is still pending. Once drug commitment has bene received, an ad hoc PRC will be scheduled. ICD review TBD. 8/4/26: RaPID held 7/16. Date of ICD review is being finalized, will be either 8/13 or 8/17. Stats PRC is scheduled for 8/26. Drug commitment from Novartis is still pending. 7/7/26: RaPID scheduled for 7/16. Drug commitment from Novartis still pending. We will continue protocol development through RaPID, but hold on stats PRC until drug commitment is received. 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 | ||
| S2702 A Randomized Phase II/III Trial of Zanzalintinib Plus Temozolomide and Gemcitabine Plus ATX-101 Versus Gemcitabine and Docetaxel in Patients with Unresectable or Metastatic Leiomyosarcoma |
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Capsule Summary Approval Date: 06/22/2026
Concept or Lol submit to NCI: 06/25/2026 Target Date: 05/23/2027 Drop Dead Date: 02/17/2028
Progress:
23
of 270 days
Current Status: 09/28/26 - F&F Call 8/26/26 - NCI Sarcoma Steering Committee (Sarcoma SC) and the NCI Gynecologic Cancer Steering Committee (GCSC) of the concept 8/4/26 - Study Chairs are reviewing SAW. September availability is being gathered for the F&F call. 7/7/26 - SAW is being drafted in preparation for upcoming F&F call 6/25/26 - Concept submitted to CTEP. Anticipated review 7/24/26. 6/22/26 - Capsule 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:
235
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. 07/06/2026: RaPID Draft circulated 07/10/2026: RaPID Review. 07/13/2026–07/24/2026: Protocol revisions based on RaPID feedback. 07/30/2026 - Imaging proposal sent to Imaging Subcommittee for review. 8/6/2026: Consent Review 08/26/2026: Statistics PRC review. 8/27/2026: StRS application submitted to SWOG Executive Committee (Streck Tube funding) September 2026: Submit protocol to CTEP. December 2026/January 2027: Target study activation. 07/20/2027: OEWG Drop Dead Date. |
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| S2703 CERULEAN: Randomized Phase II Trial of Neoadjuvant Dostarlimab Versus Post operative Standard Pathway of Adjuvant FOLFOX/CAPOX plus Atezolizumab for Localized MSI H/dMMR Colon Cancer |
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Capsule Summary Approval Date:
Current Status: 03/17/2026: Task Force meeting 04/17/2026: Call with GSK 04/24/2026: Worked on draft budget with the Study Chair 04/24/2026: Worked on draft concept document 05/01/2026: In-person Task Force meeting with GSK 06/08/2026: Touch-base meeting with GSK 06/10/2026: Statistical Protocol Review Committee review 06/10/2026: GSK medical team review 06/24/2026: Follow-up meeting with GSK 06/30/2026: Submitted concept to the SWOG Executive Committee 07/06/2026: SWOG Executive Committee review 07/22/2026: SWOG Executive Committee outcome letter received 07/29/2026: Touch-base meeting with GSK 08/21/2026: Submission to the GI Steering Committee Date TBD: Feasibility and Financial call is being scheduled for Sep. 09/21/2026: GI Steering Committee review |
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| S2706 A Randomized Phase 2/3 trial of Amivantamab + mFOLFOX vs. mFOLFOX for Previously Treated RAS/RAF WT Biliary Tract Cancer |
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Capsule Summary Approval Date:
Current Status: Apr 10, 2025 – HB TF Review Jun 18, 2025 – Stats PRC Jun 30, 2025 – Patient Advocate Meeting Jul 25, 2025 – Call with CTEP Aug 22, 2025 – Updated Design Circulated Apr 6, 2026 – SWOG EC Submission Apr 13, 2026 – SWOG EC Review May 6, 2026 – SWOG Approval Letter May 21, 2026 – Submit to HB TF for New Endorsement Jun 11, 2026 – TF Review Jun 18, 2026 – Risk Assessment Jun 24, 2026 – Discuss TF Comments Jun 25, 2026 – GISC Submission Jul 8, 2026 – Circulate SAWS Jul 15, 2026 – Withdraw Submission Jul 20, 2026 – Resubmission to Triage Jul 27, 2026 – Triage Review Aug 14, 2026 – Approval Letter Aug 17, 2026 – GISC Review Sep 9, 2026 – Study Team Meeting TBD – F&F Call Note: We plan to submit after the September deadline for November GI Steering Committee review rather than October, allowing us to better sequence protocol development efforts and assess S2703’s progress before advancing the next study. |
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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:
121
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. 6/15/26: Concept approved by GUSC. 1st drafts of protocol and consent form sent to study team. PRO permissions and drug section from DISC (cretostimogene) in process. Meeting w/CG Oncology to discuss drug logistics scheduled. RaPID scheduled for 8/11. 8/4/26: RaPID scheduled for 8/11. Budget conversations w/ CGO ongoing for drug distro vs. McKesson. TM discussions w/Natera ongoing. 9/1/26: TM proposal will be reviewed at SWOG triage on 9/14, Natera confirmed support for Streck tubes and urine collection tubes/preservative. Ongoing conversations w/ CGO using PCI as a drug distributor (McK declined support). Stats PRC scheduled for 9/9. PSR draft will be circulated soon. First submission to CTEP planned for end of October/early November. |
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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:
93
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. Study team presented to GUSC on 6/17. Pending decision. GUSC approved concept on 7/17. First draft of protocol out to study team 8/3. Meeting w/NCI on 8/6 to discuss major comments on decision letter. Pending IROC logistics call for central imaging review. RaPID poll will be out 8/4 (expected late Sept-early Oct). 9/1/26: RaPID scheduled for 10/19. PRC scheduled for 11/18. IROC reviewing and updating protocol, study team edits ongoing. |
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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:
514
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. 06/10/2026: CIRB consensus review responses submitted. 06/23/2026: CIRB approval received. 06/29/2026: RRA issued. 07/17/2026: CTEP AOH of initial protocol received, full approval pending RRA submission and approval. 07/20/2026: RRA for Revumenib submitted to CTEP. 08/03/2026: CTEP approval on hold for RRA received. 08/31/2026: CTEP Full Approval received. Target activation: 09/15/2026. |
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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:
234
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. 08/19/2026: RaPID call. 08/28/2026: ICF review call. |
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| S2701 A Phase II Randomized Study Comparing Total Marrow and Lymphoid Irradiation (TMLI) with Fractionated Total Body Irradiation (FTBI) as Conditioning for Allogeneic Peripheral Blood Stem Cell Hematopoietic Cell Transplantation (PBSC-HCT) in Patients with Acute Lymphoblastic Leukemia |
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Capsule Summary Approval Date: 06/15/2026
Current Status: 06/15/2026: Triage Approval. 08/13/2026: Internal Study Team Kick off Call. |
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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: 01/05/2026
Concept or Lol submit to NCI: 01/07/2026 Target Date: 11/23/2026 Drop Dead Date: 11/12/2027
Progress:
204
of 270 days
Current Status: 10/14/26 - Stats PRC 8/26/26- RaPID #2 Call (Consent Review) 8/12/26 - RaPID Call (Protocol Review) 6/10/26 - NCI approval on hold (waiting on drug commitment) 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. *Extended drop dead date: 11/12/2027 S2608 bi-weekly team meetings 2nd Thursday of each month 11:00 AM PT / 1:00 PM CT / 2:00 PM ET 4th Friday of each month 1:00 AM CT / 12:00 PM ET |
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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 Target Date: 08/31/2026 Drop Dead Date: 05/28/2027
Progress:
148
of 130 days
Current Status: 9/23/26: Stats PRC 9/14/26: RaPID #2 Call (Consent Review) 8/20/26: RaPID Call (Protocol Review) 6/16/26: NCI LOI Approval 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. S2612 bi-weekly team meetings 1st Thursday of each month 1:00 PM CT / 2:00 PM ET 3rd Monday of each month 3:00 PM CT / 4:00 PM ET |
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| LungMAP | ||
| S1900P A Randomized Phase II Selection Design of Sapanisertib and Paclitaxel with or without Serabelisib in Participants with NRF2 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
Concept or Lol submit to NCI: 06/25/2026 Target Date: 01/19/2027 Drop Dead Date: 10/16/2027
Progress:
57
of 180 days
Current Status: 10/28/26 - Stats PRC of the protocol 9/3/26 - RaPID 8/17/26 - Concept received CTEP Full Approval. 8/10/26 - Faeth submitted signed Drug Commitment Letter and concept received CTEP Full Approval. 7/29/26 - Concept received CTEP Approval-on-Hold. Full approval is contingent on CTEP's receipt of the signed Drug Commitment Letter from Faeth by 8/12/26. The study team is working on the first draft of the protocol. RaPID will be held on 9/3/26. Stats PRC of protocol 10/14/26. 7/23/26 - CTEP Consensus Review of official concept. OEWG timeline begins. 7/21/26 - First draft of the protocol sent to the study team for review. 6/25/26 - Official concept submitted to CTEP. The first draft of the protocol is being written. SAW has been updated and distributed. 6/17/26 - Stats PRC of concept 6/9/26 - Faeth approved revised concept to move forward to Stats PRC and CTEP submission. 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 Q3 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
Concept or Lol submit to NCI: 06/18/2026
Current Status: 9/1/2026 - Revised concept submitted 8/24/2026. 8/4/2026 - CTEP gave "Reviewing" status and requested additional information on 7/17. Study Team is working on edits. SAWs approved on 7/28, no F&F follow ups currently needed. 7/7/2026 - Concept was submitted for CTEP review on 6/18. F&F to be held offline. 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 Q3/Q4 2027 |
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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:
238
of 270 days
Current Status: 8/31/26: Pending response letter from PIO, email was sent PIO to ask for update 8/31/26. 7/31/2026 email from CTEP: "No new update as this concept is still on hold. It is my understanding that CTEP leadership has been (or will be) in communication with SWOG leadership regarding this concept." 7/7/2026: Pending CTEP decision letter, email last week, was told I can expect letter this week. 6/18/26: PIO email response: pending signature by CTEP leadership will send out letter when signature is received. 5/22/26: 2nd call with NCI MSCSC Meeting. 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
Concept or Lol submit to NCI: 06/23/2026 Target Date: 05/25/2027 Drop Dead Date: 02/19/2028
Progress:
21
of 270 days
Current Status: 8/28/26: Steering committee meeting, pending concept review decision, 8/4/26: Concept on schedule to be reviewed by CTEP steering committee 8/28/26. 7/7/26: tentatively scheduled for Concept Review Meeting 7/9/2026. 6/23/26: concept was submitted to CTEP. 5/4/2026: Triage approved concept |
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| S2617 PRIMER: Phase III Trial of Botensilimab and Pembrolizumab in Resectable Melanoma |
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Capsule Summary Approval Date: 04/28/2026
Drop Dead Date: 03/18/2028
Current Status: 8/4/2026 - Steering Committee Meeting planned for 9/25/2026. 7/7/2026 - Concept submission occurred on 6/26. 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. 3/18/2028 - Absolute deadline |
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| S2705 Phase II/III Randomized Study of Neoadjuvant Dabrafenib and Trametinib versus Neoadjuvant Ipilimumab and Nivolumab in Patients with Recurrent Resectable BRAF V600E Melanoma which is Refractory to Anti-PD1 Therapy |
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Capsule Summary Approval Date: 07/27/2026
Current Status: 7/27/2026: Triage Approved. Currently working on calls. |
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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:
428
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. 06/11/26 - Protocol reviewed by CTEP. 06/26/26 - Received CTEP Consensus Review comments. 07/07/26 - Study team is meeting with CTEP to discuss Consensus Review comments. Protocol updates in progress. Targeting response to CTEP Consensus Review by 07/10/26. 07/09/26 - Protocol resubmitted to CTEP in response to CTEP Consensus Review. 08/04/26 - According to PIO, the protocol is in the final stages of CTEP review. 08/06/26 - CTEP Follow-Up Review comments received. 08/13/26 - Protocol resubmitted to CTEP in response to CTEP Follow-Up Review comments. 09/01/26 - The protocol was resubmitted to CTEP in response to CTEP’s Follow-Up Review comments on 08/13/26 and are still pending a response. In the recent days, a SAE reporting issue was brought up and we have determined with guidance from CTEP and SDMC how to address the concerns. Based on recent conversations in the last two days we have determined we can no longer address via a memo and will be doing a pre-activation revision. Since the study still has not made it to the CIRB we cannot fully determine the new target activation date but we hope so soon and it will be after 10/15/26. 10/15/26: 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: Pending F&F via email. LKSC 7/28/26. Risk Assessment via email 6/29/26. Approved by triage 12/1/25. Reviewed by triage 11/24/25. |
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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:
388
of 270 days
Current Status: Resubmitted to CTEP 7/21/26. Consensus Review 6/30/26. Submitted 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: 9/14/2026: Next Study Team meeting. 9/1/2026: Study team currently reviewing the protocol draft. Awaiting the NOA, which was requested for today. PRO permissions form circulated to the PRO team for review. 8/17/2026: Study Team kickoff meeting held; initial protocol draft circulated. Much of the framework was pulled from S1200. 07/03/2026: Received NIH Just-In-Time (JIT) documentation request, indicating the application is likely to be funded. While awaiting the Notice of Award (NOA), the study team will begin protocol development activities to get a head start. 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
Drop Dead Date: 07/04/2027
Current Status: 9/23/26: Protocol due to DCP. 9/15/26: FDA call. (We are considering asking to push DCP deadline out if FDA call results in changes for the protocol). 9/14/26: Placeholder call to discuss FDA written response if necessary. 9/2/26: PRC. 9/1/26: Had PRO discussion. Finalized important items. Joe and Study chairs have a 9/11/26 deadline to finalize appendix/endpoints, rationale, stat section. 8/17/26: Rapid Call. Rapid #2 will occur via email and during recurring bi-weekly calls. 8/4/26: Action items. Send permissions document to PRO co-chairs. Drafting timeline related to drug procurement (creating placebo, shipping study drug to McKesson, labeling. -Asking Elliot from McKesson for input.) Continue to work on Rapid protocol draft and MCF. Items related to Contract/Drug procurement: FDA call on 9/15. Main Contract to be executed between SWOG and Reboot Rx. Sub-contract to be executed between McKesson and SWOG. 7/31/26: Received Drug Section from DISC. 7/24/26. Request for FDA meeting. 7/7/21: Continue to have biweekly meetings. Financial and Feasibility call is 7/21/26. 6/26/26: Steering Committee approved concept with recommendations. Due date for protocol is 9/23/26. 6/9/26: Steering Committee review. 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:
590
of 180 days
Current Status: 09/01/2026: Current priorities remain finalizing the GH study agreement, and completing the FDA IDE and WCG IRB submission processes, which are targeted for this month. Current WCG IRB submission target is 09/25. 08/04/2026: SWOG CTP ERC issued the Approval-on-Hold notification on 07/08 for the resubmitted protocol and informed consent document. The AZ study agreement was fully executed on 07/14. Current priorities remain finalizing the GH study agreement, followed by the FDA and WCG IRB submission processes, which are targeted for August and September. Current WCG IRB submission target is 09/25. 07/07/2026: The protocol was resubmitted to the SWOG CTP ERC on 07/01 for approval. Next steps include finalizing the collaborating company contracts and proceeding with the WCG IRB and FDA submission processes. The target timeline for IRB submission is August or September 2026. 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 signoffs 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 signoffs 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 signoffs 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 signoffs 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 signoffs 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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| 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. 5/27/2026: Concept review by Myeloma committee 6/12/2026: Concept review by Leukemia committee 7/1/2026: Hope Foundation SEED Application submitted. Awaiting notification on 9/1/26. Study Team is now aiming for October 2027 R01 submission. |
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