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
Current Status: 04/07/2025: Capsule Approved; Study Team Kick-off scheduled for 04/28. 05/13/2025: F&F Call scheduled. |
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| Cancer Care Delivery | ||
| S2417CD A Pragmatic Randomized Controlled Trial to Evaluate the Effectiveness of an Intervention called Current Together After Cancer (CTAC) to Promote Guideline-Concordant Colorectal Cancer Surveillance |
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Capsule Summary Approval Date:
Drop Dead Date: 06/12/2025
Current Status: 5/22/25: CIRB review is tentatively scheduled for5/22/25. 4/28/25: Received confirmation from CIRB that we should ask for extension. (Kate Castro agreed). 4/25/25: CIRB Initial Review (IR) Application accepted. 4/24/25: Received DCP Approval on Hold. 4/9/25: Response to pending review submitted. 4/1/25: Working on response to Pending Review. Having a call today to discuss options for collecting participant contact preferences for receiving website link and eGift card. DU agreement has not been drafted, but we will send an update to Mary when the data routing has been worked out. 3/5/25: Received second consensus review - status "Pending". Response due 4/18/25. 2/13/25: Submission accepted by DCP PIO. Next step is DCP approval on Hold and CIRB review. 2/10/25: Response to DCP consensus Review submitted. 2/3/25: Working response to consensus Review. Finalizing documents for submission to DCP. 12/5/24: Consensus Review received. Deadline for response and submission of updated documents is 2/10/25. 10/30/24: Protocol submitted to DCP. Target deadline is 4/23/25. Absolute Deadline is 6/12/25. 10/9/24: Protocol and documents to be reviewed by Stat Center PRC. Protocol due on 10/30/24. 9/23/24: Had Rapid #2. 9/6/24: Had Rapid #1. 8/5/24: Follow-up notes from F&F distributed. 8/1/24: Had F&F call. NOA grant start date is 8/1/24. 7/2/24: Sending out poll to schedule study team call and F&F call. Date for Rapid is pending. 7/1/24: Awaiting stat input of Sections 6, 10 and 11 of protocol. 6/11/24: Study chairs updated protocol template. Shared with study team. 5/31/24: Kate Castro hosted "Planning for R01 using NCORP Network" call. Protocol development timeline sent to study team. Protocol template sent to study chairs. 5/24/24: Feedback from PRO Core Team provided. 5/14/24: PRO measures table and CanCORS survivor survey was reviewed by the PROCore Team. 5/6/24: As this study scored in the 6th percentile, it will likely be funded. Kate Castro confirmed that Notice of Award would likely be sent in July 2024. PROs will be reviewed by PROCore Team later this month. Had "Next Steps" call with study team. Sent examples of SWOG protocols to Study Chairs. We will work off of the assumption that the protocol will be submitted in October 2024. F&F call and Rapid call to be scheduled soon to get dates secured on the calendar. 2/22/24: Per Dr. Vennstra, application is scheduled for study section on March 21, 2024. 10/5/23: Per Dr. Veenstra, the R01 was submitted. |
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| S2424CD A Randomized Controlled Trial of an Intervention called Patients Activated in Cancer Care through Teams (PACT) to Improve Goals of Care Communication for People with Cancer |
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Capsule Summary Approval Date:
Drop Dead Date: 01/10/2026
Current Status: 5/6/25: Working toward a 5/15/25 submission to DCP. Need Funding Memo. Katie working toward permissions for PROs. (lacking some information). 4/29/25: Received study chair edits. 4/28/25: Communicated with Shane that there will be DUA for this study (with Stanford and Emory). 4/15/25: Received PRC edits from Sarah. 3/26/25: Protocol reviewed by PRC. Comments due to me by 4/9/25. Goal is to submit protocol on 5/15/25. 3/21/25: Working toward 3/26/25 PRC. 2/19/25: NOA received. Grant start date is 3/1/25. New target activation date is 11/21/25. Absolute deadline is 1/10/26. 2/14/25: Post-rapid protocol and MCF circulated to study team for comments. Due 2/21/25. 1/31/25: Rapid call completed. Working on updates. NOA has not been received. 1/7/25: Trying to set the Rapid date for 1/31/25. Awaiting confirmation from Statisticians. 12/16/24: Kate Castro hosted R01 call. New grant start date will be 1/1/25. OEWG deadline has been updated. Target deadline is 9/23/25. Absolute deadline is 11/12/25. 12/13/24: Goal is to get the pre-RAPID study draft to the team prior to the holidays. 12/3/24: Received first draft of protocol and MCF. Asked Dr. Parikh to forward NOA document. 11/5/24: Drafting timeline. Drafting Study Assumptions Worksheet. Setting up poll for biweekly study team calls. Need to do: schedule risk assessment with Dana and set up F&F call, Start working on "Study Descriptions to facilitate PRO Permissions" spreadsheet. 10/29/24: Study chairs received their Just in Time request. Grant start date will likely be 12/1/24. (if grant start date is 12/1/24, looking at target activation of August 2025, and absolute deadline of October 2025. 9/9/24: Sent protocol template to study chairs. 8/1/24: Dr. Parikh hosted R01 check in. Went over next steps. Awaiting estimate for NOA (grant start date). Dr. Castro to host R01 expectations call in October. 6/28/24: Dr. Parikh received notification that the R01 scored in the 4th percentile therefore likely will be funded. We will await the funding decision but need to get started on next steps planning. 2/5/24: R01 submitted. 1/22/24: Approved by Triage. 11/14/23: PRO measures reviewed by PROCore Team. Recommendations distributed to study chairs on 11/15/23. |
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| comboMATCH | ||
| EAY191-S7 A Phase 2 Study Investigating Safety and Efficacy of Trastuzumab Deruxtecan (DS8201/T-DXd) and ATR Inhibitor, Ceralasertib (AZD6738) in Human Epidermal Growth Factor Receptor 2 (HER2) Positive Advanced Solid Tumors. |
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Capsule Summary Approval Date:
Current Status: 05/06/25: The study team has submitted consensus review responses to CTEP on 4.25.25. 04/01/25: The study team has a call with CTEP on April 10th from 2:30-3:30 p.m. CST to review CTEP comments. 03/04/25: The concept is under CTEP Steering Committee Review. 02/04/25: Pending Triage FYI submission and CTEP Steering Committee Submission. 01/07/25: Pending Triage FYI submission and CTEP Steering Committee Submission. 12/06/24: Approved by the ComboMATCH Steering Committee. Pending Triage FYI submission and CTEP Steering Committee Submission. |
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| Early Therapeutics & Rare Cancers | ||
| S2505 Phase III Randomized Study Testing Non-Inferiority of Shorter-Course Radiation Versus Standard Fractionation for High-Risk, Resectable Sarcoma |
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Capsule Summary Approval Date: 11/06/2024
Concept or Lol submit to NCI: 02/12/2025
Current Status: 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 |
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| SN2426 A Randomized Phase II Study of Amivantamab versus Cetuximab in Immunocompromised Patients with Recurrent Inoperable or Metastatic Cutaneous Squamous Cell Carcinoma |
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Capsule Summary Approval Date: 02/08/2024
Concept or Lol submit to NCI: 06/27/2024 Target Date: 01/12/2025 Drop Dead Date: 10/09/2025
Progress:
305
of 180 days
Current Status: 2/8/24: Triage approved capsule. F & F call- Tentatively scheduled for 3/13/24 5/16/2024: concept submitted for CTEP review 7/16/2024: CTEP concept review received 7/17/2024: teleconference with study team to discuss response. Goal to have response and updated concept within one week 8/7/2024: responses and updated concept submitted to CTEP 9/6/2024: received CTEP approval on hold with comments 9/23/2024: protocol working draft circulated to Study Chairs and SDMC 9/30/2024: concept approval 10/8/2024: receipt of concept approval 10/29/2024: RaPID meeting scheduled for 11/8/2024 11/8/2024: PRC 11/21/2024: updated draft sent to SDMC for PRC 11/27/2024: PRC 12/2/2024: received study chair post-PRC edits 12/16/2024: protocol CTEP submission 2/3/2025: Received Consensus Review and forwarded to study team 3/6/2025: Submitted Consensus Review responses to CTEP 3/21/2025: Received follow-up review and forwarded to study team 3/26/2025: Submitted follow-up review responses to CTEP 4/22/2025: Received follow-up review from CTEP and confirmed that we should not submit our response until CTEP provides the new CAEPR/risk list. |
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| Gastrointestinal Cancer | ||
| S2433 Randomized Phase III Study of Second-Line Chemotherapy with or without Panitumumab for Locally Advanced or Metastatic KRAS Wild Type Pancreatic Adenocarcinoma |
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Capsule Summary Approval Date: 04/01/2024
Concept or Lol submit to NCI: 06/10/2024 Target Date: 04/11/2025 Drop Dead Date: 01/06/2026
Progress:
306
of 270 days
Current Status: 11/1/23 - Preliminary meeting with Amgen 4/1/24 - Approved by SWOG Executive Committee and awarded # S2433. 5/3/24 - Study Team Kick off meeting 6/10/24 - Submitted concept to GISC 6/14/24 - F&F Call 6/14/24- Received PRO Core feedback. 6/26/24 - KOC with Amgen 7/15/24 - Review by GISC - Outcome is pending, with comments to address. 8/12/24 - Meeting with NCI to discuss feedback. 8/30/24 - Concept resubmitted. 9/16/24- final GISC review. 10/07/24 - GISC Approval of concept. 10/17/24 - Meeting with Vonda from Amgen to discuss updates to study design/timeline 10/24/24 - Touch base Call with Amgen 11/07/24 - Initiate Study Team Calls 12/04/24 - RaPID Call 01/03/25 - Final PRC Draft circulated 01/08/25 - Stats PRC 01/23/25 - Received review comments from Amgen 01/28/25 - Resubmitted Protocol to Amgen 02/3/2025 - Initial Protocol Submission to PIO 2/26/2025 - Received Consensus Review Comments from CTEP 3/4/2025 - Meeting with NCI to discuss comments 3/10/2025 - STrS Funding for Streck Tube Kits and Distribution approved. 3/17/2025 - Draft budget circulated to Amgen. 3/20/2025 - Resubmitted Protocol Documents to CTEP PIO. 04/03/2025 - Received additional comments from CTEP requesting the QOL surveys be made optional. 04/11/2025 - Protocol resubmitted to CTEP for review. 04/18/2025 - IND submission sent to the FDA, including a cross-reference letter provided by Amgen. 04/21/2025 - CTEP issued Approval on Hold (AOH). 04/25/2025 - Touch base call held with Amgen to discuss drug distribution logistics. SWOG and Amgen are still determining whether McKesson will serve as the distributor. 04/28/2025 - Initial submission to the NCI CIRB completed. 04/30/2025 - FDA reviewed the IND submission and determined the study is exempt from IND regulations. A follow-up call is being scheduled with Amgen to discuss the implications of this determination. 05/15/2025 - CIRB review of the protocol is scheduled. |
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| Genitourinary Cancer | ||
| S2419 Phase II/III Double Blinded Trial of Immune-Based Therapy with a Live Biotherapeutic CBM588, or Placebo for Frontline Therapy of Advanced Clear Cell Renal Cell Carcinoma (BioFront Trial) |
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Capsule Summary Approval Date: 11/27/2023
Concept or Lol submit to NCI: 07/26/2024 Target Date: 06/15/2025 Drop Dead Date: 03/12/2026
Progress:
241
of 270 days
Current Status: 11/27/23: Concept approved by triage. Currently scheduling risk assessment and F&F calls. Plan to schedule kickoff call with Osel (pharma co) after F&F call is complete. Risk assessment occurred 12/8. F&F occurred 12/18. Plan to submit to GUSC by 7/26 for the September review date. Scheduling kickoff call with Osel before then (CBM588, SWOG-held IND, placebo controlled live bacteria) Following up on action items from kickoff call with Osel (6/17), and plan to send draft budget for registration trial for their review. Plan to submit to GUSC by 7/26 for the September review date. Osel wants to pursue registrational intent with the FDA for this trial. Concept submitted to GUSC on 7/26 for 9/18 review date. Concept reviewed by GUSC on 9/18. Pending decision received 10/7. Resubmitting on 11/6 for the 11/20 GUSC review date. Reviewed on 11/20. Pending final outcome. Approved by GUSC on 12/10. Working protocol draft circulated, scheduling RaPID. RaPID scheduled for 3/6. Osel meeting held 2/3 to discuss FDA activities. Planning future call with FDA to discuss regulatory package. McKesson will do labeling for CBM588 drug and placebo. RaPID scheduled for 3/6. FDA meeting materials submitted 3/3 for late March meeting request. Blinded independent Centralized Review (BICR) discussions with IROC/imaging committee/FDA. FDA call scheduled for 5/12. 2nd RaPID scheduled for 5/23. CBM588 dose anticipated early April. Stats PRC 6/11. |
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| S2427 Bladder preservation with immunoradiotherapy after a clinically meaningful response to neoadjuvant chemotherapy in patients with muscle invasive bladder cancer (BRIGHT) |
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Capsule Summary Approval Date: 02/05/2024
Concept or Lol submit to NCI: 05/28/2024 Target Date: 01/13/2025 Drop Dead Date: 09/19/2025
Progress:
304
of 180 days
Current Status: Triage approved 2/5/2024. Risk assessment occurred 3/22. F&F call occurred 4/22. Study team updating concept. IROC RI reviewing concept and Merck support confirmed (CTEP-held IND). 5/29 submission to GUSC for 6/26 review date. Concept submitted to GUSC for 6/26 review date. Placeholder on calendar for internal discussion about steering committee questions and run through of slides for GUSC on 6/25. GUSC reviewed concept on 6/26. Pending response. Received a "pending" decision on 7/17. Study team will respond to major comments and update concept by 8/7 for 8/21 GUSC review. Study will continue to be on the OEWG timeline for the original review date (6/26). GUSC re-reviewed concept and responses to major comments on 8/21 call. Awaiting decision. GUSC approved concept 9/5. Awaiting drug commitment from Merck (CTEP CRADA). Drafting protocol and RaPID call scheduled for 11/6. MERCK committed to supplying drug on 10/19. PRC scheduled for 01/29/25. Editing post-PRC, planned 1st submission to CTEP end of Feb/early March. Planned submission to CTEP by 3/10/25. Will submit ask for Streck tubes to Merck at time of protocol submission (CTEP-held IND). Pending consistency check from Dana. Submitted to CTEP for initial review on 3/5. CTEP PRC review on 3/27. Pending Consensus Review/updates from Merck on Streck tube funding. Consensus Review received 4/2. Responses submitted 4/21. NCI lead reviewer still reviewing CR as of 5/6. Merck will not fund Streck; StRS application submitted and approved for Streck funding on 4/30. |
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| Leukemia | ||
| S2504 A Randomized Phase III Study of Pirtobrutinib plus R-CHOP vs. R-CHOP for Patients with Previously Untreated Richter Transformation (RT) |
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Capsule Summary Approval Date: 01/08/2024
Concept or Lol submit to NCI: 09/13/2024 Target Date: 08/05/2025 Drop Dead Date: 05/02/2026
Progress:
190
of 270 days
Current Status: CTEP submission 4/18/25, Amy is now PPM for this study. Stats PRC 3/19/25. F/u RaPID: 3/3/25 RaPID: 1/24/25 Protocol first draft sent 12/17/24. Concept approval 12/5/2024. S2504 concept submitted 9/13. Reviewed by LYSC on 11/08. S2421 concept was withdrawn, edits made, new study # is S2504. NCI Teleconference: 7/29. Major comments received from LYSC on 7/10/24. Will need to revise and resubmit for August or September LYSC meeting. 06/14/2024: LYSC review. 06/03/2024: Verified that concept will remain under the Leukemia Committee at SWOG but will be reviewed by the LYSC. 05/06/2024: Notified of 6/14 LYSC review, reached out to clarify that it should be LKSC, pending response. 04/29/2024: Submitted to LKSC 04/24/2024: Kick-off call with Eli Lilly 03/26/2024: F&F call. 03/12/2024: PROCore Review & recommendations submitted. 03/05/2024: PRO proposal submitted for March review. 03/05/2024: Risk Assessment. 02/09/2024: Internal Study Team Meeting. 01/22/2024: Triage approval letter received. |
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| S2507 A Phase II Randomized Study of Blinatumomab with or without Revumenib for Patients with KMT2Ar B-ALL 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: 07/16/2026
Progress:
25
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. |
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| Lung Cancer | ||
| S2409 PRISM: PRecIsion in SCLC via a Multicohort Study: Randomized Phase II studies evaluating maintenance Durvalumab with or without Biomarker-Directed Therapy for Extensive Stage Small Cell Lung Cancer (ES-SCLC) |
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Capsule Summary Approval Date: 07/12/2023
Target Date: 06/11/2024 Drop Dead Date: 09/12/2025
Progress:
520
of 180 days
Current Status: ~7/1/25 – Est. receipt of drug at McKesson based on the 12-week timeline and completion of the McKesson sub-contract and drug forecasting (+60 days for McKesson to label drugs) 4/24/25: MDACC MDUA signed 4/18/25: BG MDUA signed 4/15/25: AZ signed contract 3/24/2: Pre-Activation Revision CTEP full approval 2/26/25: Pre-Activation Revision Submission 2/3/25: Meeting with SWOG/AZ/McKesson to discuss logistics in preparation to activation 1/13/25: Submission of FDA and CIRB responses protocol versions to AZ for their review 1/10/25: CIRB Responses Submission 1/6/25: FDA Responses Submission 11/15/24: Follow Up Responses to CTEP Submission 10/30/24: Received Follow Up Comments from CTEP 10/14/24: Responses to CTEP Consensus Review and Protocol Submission 9/11/24: NCI Teleconference to discuss Consensus Review 8/30/24: Distributed NCI Consensus Review Comments 8/1/24: Initial Protocol CTEP Submission 7/10/24: Stats PRC Review 6/10/24:RaPID #2 5/22/24: RaPID #1 4/12/24: AZ provided a letter of support 2/22/24: AZ global review 2/22/24: BIQSFP Disapproval 12/14/23: TMSC Approval 10/30/23: F&F Call 9/21/23: TMSC concept/ BIQSFP submission deadline for October TMSC review date 7/12/23: Exec. Committee/Triage approved New OEWG Absolute Deadline to Activate - 9/12/25. Contracts have been signed. AZ is working on getting the drug shipment to McKesson for labeling. We are currently working on a RRA pre-activation amendment #2. |
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| S2503 A randomized phase II study of atezolizumab and JBI-802 versus investigators choice of standard of care for second or third line treatment of extensive stage small cell lung cancer (SCLC) |
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Capsule Summary Approval Date: 07/24/2023
Current Status: 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 Note: Formally, S2410 concept was disapproved by CTEP due to drug company support withdrawal. We received an updated IB from Jubilant and are now waiting on approval to move concept forward with submission from drug companies. |
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| S2509 Sequencing of IMmunOtherapy and chemoradiotherapy in unresectable stage III Non-small cell lung cancer (SIMON): A Randomized Phase II Study |
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Capsule Summary Approval Date:
Concept or Lol submit to NCI: 02/13/2025 Target Date: 12/15/2025 Drop Dead Date: 09/11/2026
Progress:
58
of 270 days
Current Status: 5/5/25 - Coordinating follow-up call with CTEP/SWOG/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. |
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| LungMAP | ||
| S1800G A Randomized Phase II Study of Casdozokitug with or without Toripalimab in Participants with Previously Treated Relapsed or Refractory Advanced Lung Squamous Cell Carcinoma (NRG Lung-MAP Non-match Sub-Study) |
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Capsule Summary Approval Date: 12/11/2024
Current Status: 5/6/2025 - Pre-Look Review is pending given CTEP leadership availability. Risk Assessment planned for 5/13. F&F planned for 5/16. 3/31/2025 - Concept CTEP submission for a Pre-Look anticipated week of 3/31. 3/4/2025 - Concept under development. 1/16/2025 - Kick-off calls; Internal 2/5, Admin 2/6, and Scientific 2/7. 1/6/2025 - Kick-off meeting scheduling in progress. DSC Approved on 12/11/2024 |
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| 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: 05/09/2026
Progress:
93
of 180 days
Current Status: Absolute Deadline: 5/9/2026 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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| 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: 01/06/2026 Drop Dead Date: 10/03/2026
Progress:
36
of 270 days
Current Status: 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 | ||
| S2431 Randomized, open-label, phase III study of anti-PD-1, anti-CTLA-4, and anti-LAG-3 antibodies in patients with previously untreated unresectable or metastatic melanoma |
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Capsule Summary Approval Date: 03/26/2024
Concept or Lol submit to NCI: 08/09/2024 Target Date: 07/15/2025 Drop Dead Date: 04/11/2026
Progress:
211
of 270 days
Current Status: 4/11/2025: Meeting with study team, BMS, and CTEP. BMS informed SWOG and CTEP that they are considering developing this concept in-house. BMS to provide final answer in May 2025. RaPID call on 4/17 canceled. 01/21/205: Concept AOH, pending BMS approval 12/24/24: Concept resubmitted to CTEP 11/15/24: Meeting with CTEP; study team working on finalizing responses and updates to submit by end of week (12/6) 10/18/24: CTEP approval pending modifications 10/1/2024: CTEP will review on 10/16 8/9/2024: Concept submitted to CTEP 8/6/2024: Concept sent to committee leadership for approval 7/2/2024: Finishing up concept; goal to submit to CTEP this week 6/4/2024: We determined to submit the concept to CTEP under the assumption that CTEP will still be the IND holder and let them make the final determination themselves since it will otherwise pretty difficult to get the investigative dose covered commercially. 5/7/2024: Drug supply discussions pending, team checking status of BMS support for nivolumab-- F&F invite to be sent for May 20th. |
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| Myeloma | ||
| S2508 Phase II Study of Optimal Induction and MRD Driven Maintenance Therapy for Patients with Newly Diagnosed High-Risk Multiple Myeloma (HRMM) |
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Capsule Summary Approval Date: 02/25/2025
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. |
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| myeloMATCH | ||
| 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: 07/16/2026
Progress:
25
of 270 days
Current Status: LKSC approved 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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| 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:
101
of 180 days
Current Status: 05/06/25: CTP ERC has approved concept, and pending startup agreement execution. 04/01/25: CTP ERC has approved concept, and pending startup agreement execution. 03/04/25: CTP ERC has approved concept, and pending startup agreement execution. 02/04/25: Study Team is working on the updated CTP ERC responses. 01/07/25: Submitted the responses to the CTP ERC on 12/12/24. 12/03/24: The study team is working on CTP ERC responses. 11/01/24: The study team is working on CTP ERC responses. 10/01/24: Received CTP ERC Capsule Outcome Review Letter on 09/23/24. The study team is working on responses. 09/03/24: CTP ERC reviewed the concept on 8/20, pending ERC review letter. 08/06/24: The capsule will be presented to CTP ERC on 8/20 for their review. 07/01/24: The updated capsule and budget have been submitted to AZ. The study team is pending approval of the capsule/budget and ERC approval. 06/04/24: The updated capsule and budget have been submitted to AZ. The study team is pending approval of the capsule/budget and ERC approval. 05/07/24: Negotiation discussions are ongoing with one of the collaborators (AZ). The study team is pending collaborator approval of the capsule and ERC approval. |
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| 21CTP.HN01 Phase I/II Study of Amivantamab carboPlatin and pacliTaxel in recurrent metastatic Head and Neck cancer (APT-HN) Study Synopsis |
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Capsule Summary Approval Date: 11/07/2022
Concept or Lol submit to NCI: 09/22/2022 Target Date: 07/08/2023 Drop Dead Date: 04/03/2024
Progress:
949
of 270 days
Current Status: 05/06/25: Study Team submitted responses back to CTP ERC on 4/16/25. 04/01/25: Study Team is working on responses to CTP ERC due back 4/18/25. 03/14/25: CTP ERC Responses sent to study team. 03/04/25: Pending CTP ERC Review responses. 02/18/25: CTP ERC Review of study documents. 02/04/25: CTP ERC review for study documents schedule for 2/18. 01/07/25: Updating post PRC comments. 12/03/24: Stats PRC review is scheduled for Wednesday, December 18th. 11/01/24: RAPID Call is scheduled for Friday, November 15, 2024. Invite has been circulated. 10/01/24: Finalizing the pending contract execution before protocol development. 09/03/24: No new updates. Pending contract execution before protocol development. 08/06/24: No new updates. Pending contract execution before protocol development. 07/01/24: No new updates. Pending contract execution before protocol development. 06/04/24: No new updates. Pending contract execution before protocol development. 05/04/24: No new updates. Pending contract execution before protocol development. 03/05/24: No new updates. Pending contract execution before protocol development. 02/06/24: Pending contract execution before protocol development. 01/09/24: Pending contract execution before protocol development. 11/07/22: Capsule approved by ERC. |
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| 21CTP.LEUK01 A Phase II Trial of Asciminib, Dasatinib, Prednisone, and Blinatumomab for Patients with Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Acute Lymphoblastic Leukemia |
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Capsule Summary Approval Date: 02/20/2023
Concept or Lol submit to NCI: 02/20/2023 Target Date: 11/17/2023 Drop Dead Date: 08/13/2024
Progress:
817
of 270 days
Current Status: 05/06/25- Site Feasibility Survey will be circulated to sites 4/1. Pending site agreements. 04/01/25- Site Feasibility Survey will be circulated to sites 4/1. Pending site agreements. 03/04/25- WCG IRB has approved study documents. Targeting the beginning of Q2 2025 activation. 02/24/25- We received WCG IRB approval letter. 02/04/25- WCG IRB is reviewing study documents. Targeting the beginning of Q2 2025 activation. 01/28/25- Submitted Pre-Activation Revision #3, and received approval on 1/28/25. 01/07/25- Submitting to the WCG IRB. Targeting end of Q1 2025 activation. 12/03/24- Received approval from MCA. 12/02/24- Received Approval on Hold for Pre-Activation #2. 12/03/24- Awaiting to hear back from FDA, then will submit to WCG IRB. Targeting end of Q1 2025 activation. 11/01/24- Pre-Activation Revision #2 is under internal review. 10/01/24- Currently working on Pre-Activation Revision #2. 09/06/24- Received FDA approval letter “Study May Proceedâ€. 09/03/24- FDA review comments responses submitted; updated protocol will be re-submitted by 9/9. 08/06/24- Study team received Approval on hold letter on 7.29.24. Currently working on Pre-Activation Revision #1. Site Selection letters have been sent out. 07/29/24- Approval on hold letter received from CTP ERC. 07/01/24- Study team working on CTP Executive Review Responses. 06/01/24- Waiting for CTP Executive Review Responses 5/21/24- CTP Executive Review Committee 4/17/24- PRC Stats Review 03/22/24- 2nd RAPID Call scheduled 02/16/24- RAPID Call scheduled 01/01/24- Working on First Draft Protocol 12/08/23- Contract Execution- 12/08/23 02/20/23- SWOG CTP Executive Review Committee (ERC approved capsule |
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| Symptom Control and Quality of Life | ||
| S2415 TRACE “Testing Response to Acupuncture in Metastatic Breast Cancer†|
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Capsule Summary Approval Date: 09/11/2023
Current Status: 10/17/24: R01 was reviewed (Score 31, Percentile: 15.0) 6/4/24: R01 Resubmission 10/5/23: R01 Submission 9/11/23: Triage as FYI 8/16/23: Stats PRC Close to fundable, but likely requires NCI advocacy to secure funding. The study has been moved to the Palliative and End of Life Committee but will remain under the Symptom Management & Survivorship Committee until the R01 is approved. |
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| S2435 Phase III Trial of an App-delivered Sleep Coaching Intervention in Post-Treatment Survivors of Diverse Cancers and their Bedroom Partners |
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Capsule Summary Approval Date:
Current Status: **R01 SUBMISSION for June 2024** PRC review 5/8. PRO Core team reviewed 5/14. Triage informally approved on 5/13. Pat Mize determined no need for mini F&F. R01 submitted June 5th. Response expected Q4 of 2024. Reassigned to a special panel that will meet on 11/21. Initial result expected soon after and comments expected late December. 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. |
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