Protocol Tracking Reports: Dashboard

Disease Committee:  

  On Schedule     Current Segment Started Late     Missed Milestone
Breast Cancer
Randomized Phase III trials of multimodality therapy versus palliative therapy in triple-negative (TNBC) and HER2 positive (HER2+) de novo (AJCC stage IV) oligometastatic breast cancer.
Capsule Summary Approval Date: 02/12/2024 

Current Status:
03/05/24: Triage approved on 02/12/24. In the process of scheduling the F/F call. Aiming for 04/16/24 BCSC Review.
Cancer Care Delivery
Preventing Financial Adversity Among Early-Stage Cancer Patients Through Unrestricted Cash (PAYMENT)
Capsule Summary Approval Date: 02/13/2023 

Current Status:
12/4/23: Update: Scientific Merit Review is in March 2024 and the advisory council review in May 2024. Earliest start date would be July 2024.
10/25/23: Resubmitted on 10/25/23.
7/11/23: Dr. Shankaran received summary statement and impact score, but didn't hear anything from program officer about a funding decision. They are planning a re-submission in November unless they hear the project will be funded before then.
6/6/23: Scientific Merit Review should come through in July. Advisory Council Reviews are scheduled for October 2023. Should the study receive funding, earliest start date is December 2023.
Presented to Executive Officers on 2/13/23. Grant submitted 2/24/23.
A Pragmatic Randomized Controlled Trial to Evaluate the Effectiveness of an Intervention to Promote Guideline-Concordant Colorectal Cancer Surveillance
Capsule Summary Approval Date:  

Current Status:
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.
Randomized Controlled Trial of a Lay Health Worker-led Intervention to Promote Goals of Care Communication
Capsule Summary Approval Date:  

Current Status:
Approved by Triage 1/22/24.
R01 submission due 2/5/24.
Cancer Survivorship
Testing the Fatigue Reduction Diet in People with Early Stage Breast Cancer: A Randomized Controlled Trial, The GUIDE Study
Capsule Summary Approval Date: 01/22/2024 

Current Status:
Study introduction call w/ Pat Mize occurred 11/6/23

PRC occurred 12/21/23 and comments were sent back to the study team

PRO Core team will reviewed 1/9/24 .Comments back to team 1/12/24

New DCP leadership reviewed docs on 1/12 and approved to move forward

Pat Mize confirmed that a mini F&F was not needed.

Triage reviewed informally on 1/22/24. Aiming for early Feb R01 submission.

R01 submitted early Feb. Expecting response May/June.
CAMELOT Phase II Basket Trial: ATR inhibitor Camonsertib and PKMYT1 inhibitor Lunresertib combination in advanced solid tumors with CCNE1 amplification or deleterious alterations in FBXW7 or PPP2R1A
Capsule Summary Approval Date:  
Early Therapeutics & Rare Cancers
Phase II Randomized Study Testing Non-Inferiority of Standard Fractionation Versus Shorter-Course Radiation for High-Risk, Resectable Sarcoma
Capsule Summary Approval Date: 01/29/2024 

Current Status:
3/4/24: F &F call held, planning to submit concept on or before 4/1/2024.
2/5/24: F & F call is pending scheduling; meeting poll is being circulated.
1/29/24: Triage approved the capsule.
1/8/24: Triage reviewed updated capsule and study chairs triage response letter internal on 1/8/24 triage meeting. Executive Officers decided they want study chair to join upcoming triage meeting to discuss new study design, conversations SC had with the interested institutions and NCI. Tentatively scheduled for 1/29/24 triage meeting.
6/6/23: Dr. Harris is reviewing survey results and preparing a response letter for Dr. Ryan.
4/14/23: proposal received an approval on hold pending a response to the outcome of a survey. Committee is concerned about the feasibility to conduct this study. The Committee requests the study team to survey institutions (large institutions and community sites) to determine if there is an equipoise and interest in registering participants to the study.
A Randomized Phase II Study of Temozolomide in Combination with Atezolizumab (Tem-Atezo) versus Temozolomide Alone in Adults with Advanced Bronchopulmonary Neuroendocrine Tumors.
Capsule Summary Approval Date: 01/29/2024 

Current Status:
2/6/24: capsule approved by triage.
A Randomized Phase II Study of Amivantamab versus Cetuximab in Immunocompromised Patients with Recurrent Inoperable or Metastatic Cutaneous Squamous Cell Carcinoma
Capsule Summary Approval Date: 02/08/2024 

Current Status:
2/8/24: Triage approved capsule.
F & F call- Tentatively scheduled for 3/13/24
A phase Ib/II study of encorafenib, binimetinib & regorafenib in advanced or metastatic BRAF V600E mutated solid tumors that have progressed on prior RAF +/- MEK inhibition
Capsule Summary Approval Date:  

Current Status:
2/22/2024: Triage approved capsule.
Gastrointestinal Cancer
Phase II/III Trial of Nivolumab + Cabozantinib or Nivolumab + Paclitaxel + Ramucirumab versus Paclitaxel + Ramucirumab in Patients with PD-L1 CPS > 5 Advanced Gastric and Esophageal Adenocarcinoma
Capsule Summary Approval Date: 08/15/2022 
Concept or Lol submit to NCI: 11/21/2022 
Target Date: 09/15/2023 
Drop Dead Date: 06/11/2024 
Progress: 493 of 270 days

Current Status:
8/8/22 Submitted for Exec Review
8/15/22 Capsule Approved by SWOG
10/24/22 FF Call
11/08/2022 PRO Core
11/21/2022 Concept submitted to CTEP
12/19/2022 Concept review date
1/20/2023 NCI Call
2/6/23 Concept Resubmission
2/27/2023 CTEP Review
3/8/23 CTEP Approval Received
3/8/23 Drug commitment requested from BMS for Nivolumab/Approved
6/6/23 RaPID
7/12/23 PRC pending outcome of RaPID
8/4/23 Submitted Protocol to CTEP.
8/15/23 Permission for PRO Instruments obtained.
8/29/23 Finalizing StRS application for streck tubes.
9/29/23 Meeting with NCI to review Consensus Review Comments
10/11/23 Submitted response to Consensus Review Comments - still at CTEP.
10/11/23 Received NCA draft. Anticipate pre-act. revision to correct the billing issues that were identified.
11/6/23 STrS application reviewed and approved.
11/20/23 Submitted pre-activation revision to address billing concerns/CTEP comments.
12/27/23 CTEP-Approval on hold
01/03/24 CIRB Application submission
01/18/24 CIRB review meeting
02/07/24 CIRB re-submission due
2/15/24 CIRB Approval
3/4/24 CTEP Outcome Letter pending.
*Additional NCA billing issues were identified, and the study team will submit a pre-activation revision to correct.
4/1/24 Targeted Activation
A Randomized Phase II Trial of Regorafenib, Ipilimumab, and Nivolumab versus Trifluridine/Tipiracil plus Bevacizumab in Metastatic Colorectal Cancer Without Liver Metastases
Capsule Summary Approval Date:  

Current Status:
12/18/24 Triage Review and Approval
12/22/24 Triage Letter received
2/13/24 PRO Proposal review
2/16/2024 PRO feedback received
2/26/2024 F&F Call
3/4/2024 Finalizing Concept documents
3/18/2024 Submission to GISC
4/15/2024 GISC review
Genitourinary Cancer
A Phase III Study of Cabazitaxel with or without Carboplatin in Patients with metastatic castrate-resistant prostate cancer (mCRPC), Stratified by Aggressive Variant Signature
Capsule Summary Approval Date: 04/19/2023 
Concept or Lol submit to NCI: 05/24/2023 
Target Date: 03/17/2024 
Drop Dead Date: 12/12/2024 
Progress: 309 of 270 days

Current Status:
**Planned Activation Date: 06/15/2024**
**Drop Dead Date: 12/12/2024**

Triage approved capsule and TM proposal 4/19/23.

F&F call held on 5/1. Aiming for 5/24 GUSC submission deadline for their 6/21 review. BIQ application will also be submitted for integral TM to GUSC.

Concept and BIQ docs submitted to GUSC for 6/21 review.

Concept and BIQ reviewed on 6/21 by GUSC. Pending response from GUSC.

Response from GUSC received 7/7 (Decision: Pending). Dr. Corn will respond to comments and submit by 8/2 for the 8/16 review date.

Response submitted to 2nd round of comments from GUSC on 8/18 for 9/20 review.

Concept re-reviewed by GUSC on 9/20. Currently waiting on response from GUSC and drafting protocol. Plan to poll for RaPID times before Group Meeting.

GUSC approved concept on 10/13. 1st protocol draft sent to team before RaPID meeting planned for 12/4. Still waiting on GUSC decision for BIQ funding.

GUSC approved BIQ funding on 11/17. RaPID call occurred 12/4. Plan to hold TM F&F call.

TM F&F call occurred 12/20. Stats PRC will be scheduled after Dr. Corn returns from leave on 1/16.

PRC occurred on 1/31. Aiming for first CTEP submission end of February.

Submitted to CTEP for initial review on 2/29. Currently drafting additional DCT language for consensus review.
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)
Capsule Summary Approval Date: 11/27/2023 

Current Status:
11/27/23: Concept approved by triage. Currently scheduling risk assessment and F&F calls. Plan to schedule kickoff call with Osel (pharma co) after F&F call is complete.

Risk assessment occurred 12/8. F&F occurred 12/18.

Study team has decided to postpone submission to GUSC until June - Osel is conducting a preliminary trial and dose results will be available for CBM-588 at this time.
Bladder preservation with immunoradiotherapy after a clinically meaningful response to neoadjuvant chemotherapy in patients with muscle invasive bladder cancer (BRIGHT)
Capsule Summary Approval Date: 02/05/2024 

Current Status:
Triage approved 2/5/2024.

Risk assessment scheduled for 3/20.

F&F call scheduled for 4/22.
A Randomized Phase 2 Trial to Evaluate the Efficacy of Bcl-2 Inhibitor Therapy with Chemotherapy Compared to Chemotherapy Alone in Adult Patients with Newly Diagnosed T-Cell ALL and T-Cell Lymphoblastic Lymphoma
Capsule Summary Approval Date: 12/12/2022 
Concept or Lol submit to NCI: 11/29/2022 
Target Date: 07/23/2023 
Drop Dead Date: 04/18/2024 
Progress: 457 of 180 days

Current Status:
11/21/2022: Study number administratively assigned.
11/21/2022: Submitted for triage.
11/22/2022: Submitted to LKSC.
11/28/2022: Triage scheduled.
11/29/2022: Updated LKSC documents submitted.
12/12/2022: Triage approved.
12/27/2022: LKSC scheduled (cancelled).
01/24/2023: LKSC occurred.
02/13/2023: F&F occurred.
03/06/2023: Notified of BIQSFP approval.
03/24/2023: RaPID occurred.
04/09/2023: CTEP requested drug agreement response deadline
05/17/2023: PRC occurred.
06/09/2023: Follow-Up RaPID occurred.
06/29/2023: CTEP submission
07/26/2023: CTEP Consensus review received.
08/07/2023: NCI call.
8/28/2023: CTEP Re-submission.
08/29/2023: CTEP rejected submission due to company comments not sent. CTEP sent company comments, study team is working on responses.
09/06/2023: Re-submitted to CTEP.
09/26/2023: CTEP consensus review received.
10/11/2023: CTEP re-submission occurred.
11/02/2023: CTEP approval on hold received.
12/07/2023: CIRB review occurred.
01/03/2024: CIRB approval received.
01/05/2024: Pre-activation revision in works, pending submission once CTEP full approval is received.
01/29/2024: DTL approved.
02/02/2024: Pre-activation revision submitted, still pending FDA comments.
02/14/2024: Pre-activation revision received CTEP AOH.
02/21/2024: Pre-activation revision received CIRB approval.
02/23/2023: Pre-activation revision received CTEP AOH.
03/04/2024: CRADA negotiations for Navitoclax are still ongoing. CTEP FDA submission pending negotiations finalization.
04/11/2024: OEWG extension requested.
A Randomized Phase II Study of Pirtobrutinib plus R-CHOP vs. R-CHOP for Patients with Previously Untreated Richter Transformation (RT)
Capsule Summary Approval Date: 01/08/2024 

Current Status:
01/22/2024: Triage approval letter received.
02/09/2024: Internal Study Team Meeting.
03/05/2024: Risk Assessment.
03/05/2024: PRO proposal submitted for March review.
03/12/2024: PROCore Review & recommendations submitted.
03/26/2024: F&F call scheduled.
04/24/2024: Pharma kick-off call scheduled.
A Phase 1B Study Assessing the Safety and Activity of SNDX-5613 (revumenib) in Combination with Age-Modified Chemotherapy in Newly Diagnosed Patients with KMT2Ar Acute Lymphoblastic Leukemia (ALL) or Acute Leukemia with Ambiguous Lineage (ALAL)
Capsule Summary Approval Date: 04/22/2024 
Concept or Lol submit to NCI: 08/29/2023 
Target Date: 01/29/2024 
Drop Dead Date: 10/25/2024 
Progress: 217 of 130 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.
Lung Cancer
Neoadjuvant Chemo-durvalumab for Clinical Stage I, 2-3.9cm, Non-small Cell Lung Cancer a Single-arm Trial
Capsule Summary Approval Date: 05/04/2023 

Current Status:
05/04/23: Exec. Committee/Triage approved.

08/01/23: Study team is working on the LOI for redesign and working on BIQSFP submission.

09/05/23: Study team is reviewing the revised Concept and preparing for further discussions regarding the BIQSFP in anticipation of the TMSC concept submission in mid-October.

10/03/23: Study team is continuing to address Concept revisions and address outstanding questions regarding the study design and the patient eligibility, specimen flow and drug/testing funding. The team has decided to postpone the submission to the TMSC until these questions have been addressed. The Risk Assessment call was held on 09/29 and the F&F meeting is scheduled for 10/06. An additional F&F meeting may be scheduled as needed following the 10/06 meeting.

11/07/23: Study team is continuing to address Concept revisions and provide responses to the TM logistical aspects, including specifications for pCR tissue processing and blood/plasma for ctDNA analysis. The study team held a second F&F meeting to provide responses to the questions on Friday (11/03) but many details still need to be ironed out. The study team is also pending a response from AstraZeneca regarding funding for the neoadjuvant chemo agents and biomarkers tests. We are going to delay submission to CTEP TMSC until December to ensure the TM logistical components are outlined completely in the Concept before the OEWG timeline starts.

12/05/23: The study team is continuing to address Concept revisions and provide responses to the TM logistical aspects, including specifications for pCR tissue processing and blood/plasma for ctDNA analysis. The study team still anticipates a submission to CTEP TMSC by 12/14, as we plan to proceed with the understanding that AstraZeneca will fund the neoadjuvant chemo agents and biomarker tests.

01/09/23: It was determined right before the holidays that AstraZeneca would not be able to proceed with support of the concept as their internal priority/strategy on the stage I NSCLC disease setting has shifted over the last year and the current proposal doesn’t align with their mission moving forward into 2024. That said, the study chairs are pursuing discussions with other pharma partners (including Merck) to identify funding support for the neoadjuvant chemo agents as well as the biomarker tests. The concept will undergo some revisions in the coming weeks to reflect the changes in study design as conversations develop with the pharma groups in hopes of receiving the financial support needed in order to submit the concept to CTEP in Q1 2024.

02/06/24: The study team is continuing to refine the concept and develop budget estimates following the January 10th teleconference with Merck. A follow up call is scheduled with Merck for Wednesday, February 7th for further discussion on study redesign details, including the consideration for a single arm, phase II trial with pCR as the primary endpoint. Additional meetings for funding support are being considered with Genentech and Regeneron.

02/06/24: The study team is continuing to hold discussions with other potential collaborators (Genentech, Regeneron, etc.) for funding support.
Accelerating Drug Efficacy Evaluation thru Growth Rate and Overall Survival Correlations
Capsule Summary Approval Date: 06/02/2023 

Current Status:
02/20/24 - The proposal will be reviewed by the NCI Clinical Imaging Steering Committee (CISC)
CTIU had an informal review with the FDA and provided the study team with feedback
10/10/23 - Study team submitted responses.
10/03/23 - The study team is addressing comments with re-submission due 10/10.
07/13/23 - CTIU Proposal Submission
We are in communication with the study team on scheduling a call to further discuss the proposal in August.

(CTIU 23-4 and 23-14)
PRISM: A Multicohort PRecIsion SCLC Subtype Maintenance Phase II Trial of Durvalumab Versus Biomarker-Directed Novel Agents in Combination with Durvalumab in Extensive Stage Small Cell Lung Cancer (ES-SCLC)
Capsule Summary Approval Date: 07/12/2023 
Target Date: 06/11/2024 
Drop Dead Date: 03/08/2025 
Progress: 133 of 180 days

Current Status:
7/12/23 - Exec. Committee/Triage approved
9/21/23 - TMSC concept/ BIQSFP submission deadline for October TMSC review date
10/30/23 - F&F Call
12/14/23 - TMSC Approval
2/22/24 - BIQSFP Disapproval
2/22/24 - AZ global review

AZ has reviewed the concept during their global review. One point that arose was their preference for using only durva in the induction phase, rather than allowing a switch from atezo. We expressed our concerns and requested that the protocol remain unchanged, or alternatively, allow for at least 2-3 cycles to be given with durva (which would still permit the first or second cycle to be given with atezo). Marnie is bringing that back with the support of her leadership that we met with at TTLC. Study chair will provide us with updates as they become available.

Absolute Deadline: 03/08/2025
A randomized phase II study of a PDL1 inhibitor and iadademstat (ORY-1001) versus investigators choice of standard of care for second line treatment of extensive stage small cell lung cancer (SCLC)
Capsule Summary Approval Date: 07/24/2023 
Target Date: 05/14/2024 
Drop Dead Date: 02/08/2025 
Progress: 161 of 180 days

Current Status:
7/24/23 - Exec. Committee/Triage approved
9/18/23 - F&F Call
11/16/23 - TMSC Review
12/14/23 - Approval on Hold; Pending Oryzon drug commitment
2/12/24 - RAPID Call
2/27/24 - TMSC Disapproval due to iadademstat unable to be provided for this study

Study team is exploring other drug options with Merck.

INcorporating pathologic reSponse in patIents with early staGe lung cancer to optimize immunotHerapy in the adjuvanT setting (INSIGHT)
Capsule Summary Approval Date: 08/21/2023 
Concept or Lol submit to NCI: 08/24/2023 
Target Date: 06/17/2024 
Drop Dead Date: 03/14/2025 
Progress: 217 of 270 days

Current Status:
03/08/24: Target CTEP initial protocol submission
02/21/24: Stats PRC; Comments are being incorporated
02/09/24: Call with Nationwide on the TM proposal logistics and budgeting
02/06/24: Rapid is scheduled
01/09/24: Discussion with CTEP/AZ on stats design
11/10/23: Second F&F Call scheduled
11/05/23: First draft of the protocol circulated
10/27/23: First F&F call conducted
10/13/23: Received Concept Approval
10/03/23: Pending TSMC review
09/05/23: Concept is scheduled for a 9/21/23 TMSC Review
08/21/23: SWOG Triage Approved
A Randomized Phase II/III Study of Docetaxel and Ramucirumab with or without Cemiplimab for Participants Previously Treated with Immunotherapy for Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Non-Matched Sub-Study)
Capsule Summary Approval Date: 04/01/2022 
Concept or Lol submit to NCI: 09/21/2023 
Target Date: 08/12/2024 
Drop Dead Date: 11/16/2023 
Progress: 161 of 270 days

Current Status:
OEWG start date: 11/16/23
Drop Dead date: 5/9/25

4/18/24 - SWOG and Regeneron met for their third planning call to prepare for the FDA formal meeting that is anticipated in mid-June.

4/11/24 - Updated post-Stats PRC protocol sent to Regeneron. Regeneron will need about 10 business days to review and provide comments. Initial protocol submission to CTEP anticipated in April.

4/9/24 - Stats PRC comments received from SDMC.

4/2/24 - Once Ops receives SDMC's Stats PRC edits, the protocol and consent will be updated and sent to Regeneron for review. Initial protocol submission to CTEP anticipated in April.

3/27/24 - Stats PRC

3/13/24 - RAPID

3/1/24 - Regeneron provided comments for the first protocol draft.

2/26/24 - Received CTEP Full Approval of Concept

2/20/24 - Regeneron signed and submitted the Drug Commitment Letter to CTEP.

2/15/24 - Updated first protocol draft sent to Regeneron for review. Their edits/comments are due 3/1/24.

2/6/24 - Study team comments for first protocol draft are being incorporated into the second draft. RAPID anticipated in March. The Regeneron legal team is of the understanding that NCI told Regeneron that execution of the CTPA would constitute the drug commitment and the Drug Commitment Letter as a stand-alone document for S1800E is not necessary. However, the signed Drug Commitment Letter is due to CTEP by 4/8/24. FNIH and the SWOG legal team are working to rectify the disconnect about what is required and when.

1/25/24 - First protocol draft sent to the study team for review. Edits/comments are due 2/1/24.

1/8/24 - The revised concept received Approval On Hold on 1/8/24. Full Approval of the concept is contingent upon CTEP's receipt of Regeneron's Drug Commitment Letter for cemiplimab.

12/5/23 - Regeneron is reviewing the revised phase II/III design and will provide their feedback to the Lung-MAP team in the coming week. If Regeneron approves this design, a revised official Concept will be submitted to CTEP in December. S1800E has not yet been added to the OEWG timeline.

11/27/23 - Call with Regeneron to review CTEP feedback and phase II/III design.

11/24/23 - Revised concept with phase II/III design sent to Regeneron.

11/21/23 - Received CTEP comments. CTEP stated they would not approve a straight phase III study without phase I and phase II data. CTEP suggested the study team modify the design to be a phase II/III.

11/16/23 - CTEP review of S1800E Concept and supplemental Study Design and Interim Analysis Plan.

11/15/23 - Study team submitted a S1800E Study Design and Interim Analysis Plan for CTEP review. This document supplements the S1800E Concept.

11/7/23 - Official Concept remains with CTEP. According to PIO, Phase III designs must be reviewed by TSMC. This does not align with the standard review procedure for Lung-MAP concepts. Ops has followed up with PIO/CTEP on a weekly basis to request the review date. After 4 weeks, a date still has not been identified.

10/30/23 - Feasibility & Finance Meeting

10/5/23 - Risk Assessment Call

10/3/23 - Scheduling Feasibility & Finance Meeting

9/21/23 - Official Concept with Phase III design submitted to CTEP

9/5/23 - SWOG Leadership has reviewed and approved the revised concept. The study team will meet with Regeneron on 9/18/23 to discuss Regeneron's review comments. Once Regeneron provides their approval the concept will be submitted to CTEP.

8/7/23 - The study team and Regeneron have agreed to move forward with a Phase III design. The concept is being updated in preparation for CTEP submission.

8/1/23 - The study team will meet with Regeneron again on 8/7/23 to continue discussing the statistical design.

7/11/23 - The study team had a call with Regeneron on 7/6/23. Their leadership team is supportive of the concept, but want to go back to assessing for primary endpoint in all-comers irrespective of PD-L1 status. They are still going back and forth on statistical issues (They want to increase the hazard ratio to 0.65 instead of 0.63 and sample size will probably need to go up to around 380). There is a follow up call on 7/17/23.

6/6/23 - Study team is meeting with Regeneron on 6/7/23 to discuss the study's updated statistical design.

5/2/23 - Study team met with Regeneron 5/1/23. Regeneron confirmed they will not support the study unless it is a Phase II/II and has the primary analyses population of PD-L1 >1%. The study team agreed to wait until Regeneron provides their internal review and approval of the Concept (planned for the end of May) before reaching out to CTEP again.

4/4/23 - Study has changed from a Phase II to a Phase II/III. Regeneron is interested in registrational intent. Last study call held 4/3/23. Regeneron is reviewing the concept and will have comments in the next 1-2 weeks. Study team is looking into eligibility updates.

3/6/23 - Call with CTEP scheduled for 03/09/23 to review pre-look comments. Still pending updates/edits from Regeneron on Concept. Study call scheduled for 03/09/23.

2/15/23 - Pre-look comments received from CTEP

2/7/23 - Revised Concept pending company review with feedback expected later this month. Revised Concept was submitted to CTEP for a second pre-look on 1/26/23. The study team will address CTEP's initial comments in conjunction with comments received from the company review and update the Concept in preparation for an initial submission.

1/26/23 - Revised Concept submitted to CTEP for pre-look

1/9/23 - Concept has been updated to include a stand-alone randomized Phase II design, and it has been sent to Regeneron for review.

9/8/22 - CTEP has put the pre-look on hold due to accrual concerns with Pragmatica.

7/22/22 - Concept Submitted to CTEP for pre-look

5/5/22 - Company KOC

4/1/22 - DSC approved
A Phase II Study of Amivantamab-vmjw in Participants Previously Treated with High MET-Amplification for Stage IV or Recurrent Non-Small-Cell Lung Cancer (Lung-MAP Sub-Study)
Capsule Summary Approval Date: 08/29/2022 
Concept or Lol submit to NCI: 02/01/2023 
Target Date: 08/15/2023 
Drop Dead Date: 05/11/2024 
Progress: 434 of 180 days

Current Status:
Target activation 5/1/24
Drop Dead 5/11/24
4/16/24 - Ops submitted an OEWG extension to CTEP. The request will officially be reviewed on 5/3/24. After the CTEP OEWG Committee meets on 5/3/24, they will provide SWOG with an absolute deadline.
4/2/24 - Janssen contract execution anticipated in early April.
3/5/24 - Janssen contract execution anticipated in March.
2/6/24 - Janssen contract execution anticipated in the coming month.
1/9/24 - Janssen contract execution anticipated in the coming month.
12/5/23 - Target contract execution in late December 2023 or early Q1 2024.
10/27/23 - Received CIRB Final Approval of Initial Review
10/17/23 - Responded to CIRB Initial Review comments
10/12/23 - CIRB Initial Review comments received
10/5/23 - CIRB Initial Review
9/20/23 - Minor FDA recommendations received (no clinical hold)
9/8/23 - Received CTEP AOH and Submitted to CIRB
9/6/23 - S1900J Submitted to the FDA
8/25/23 - Responded to CTEP Follow-Up Review comments
8/18/23 - CTEP Follow-Up Review comments received
8/3/23 - Responded to CTEP Consensus Review Comments
7/11/23 - CTEP Consensus Review comments received
6/29/23 - CTEP Consensus Review of protocol
6/2/23 - Initial protocol submission to CTEP
5/15/23 - Janssen review comments received
5/3/23 - Stats PRC of protocol
4/25/23 - Received CTEP Full Approval of concept
4/7/23 - RaPID
3/28/23 - Response to CTEP concept Consensus Review comments submitted
3/2/23 - CTEP concept Consensus Review comments received
3/2/23 - Feasibility & Finance Call
2/9/23 - Risk Assessment
2/16/23 - CTEP PRC of concept
2/10/23 - First draft of protocol sent to the study team
2/1/23 - Official concept submitted to CTEP
1/18/23 - Stats PRC of concept
1/5/23 - NCI call to discuss pre-look comments
12/6/22 - Study team is finalizing responses to CTEP pre-look comments
11/29/22 - Pre-look comments received from CTEP
10/26/22 - Concept pre-look submitted
10/13/22 - Company Kick Off Call
10/11/22 - Internal Kick Off Call
10/3/22 - Study team is working on study design/ concept
8/29/22 - DSC Approved
A Phase II Study of Trastuzumab Deruxtecan (T-DXd) in HER2 Wild-Type, HER2 (ERBB2) Amplified Relapsed/Refractory Advanced Non-Small-Cell Lung Cancer (Lung-MAP Sub-Study)
Capsule Summary Approval Date: 12/04/2023 

Current Status:
4/2/24 - Daiichi Sankyo will review the concept on 4/18/24. The Lung-MAP team expects to receive feedback from Daiichi Sankyo in late April or early May. Anticipating CTEP pre-look submission in May.
3/7/24 - Concept submitted to Daiichi Sankyo for review via their portal.
3/5/24 - Concept has been entered into Daiichi Sankyo portal. Submission is pending entry of the draft budget. This will be added this week. Anticipating CTEP pre-look submission in late March.
2/27/24 - Concept reviewed and approved by Lung and Lung-MAP Leadership.
2/22/24 - Daiichi has explained that for legal reasons we must submit the Concept to them via their portal. Therefore, to move development forward, SWOG leadership has determined that they will allow the Network Operations Center to submit the S1900M Concept accordingly.
2/9/24 - Internal Kick Off Call
2/5/24 - Study team met to discuss the study design and work on the concept form. Anticipated completion of the concept form 2/16/24. Concept will be reviewed by Daiichi Sankyo prior to CTEP pre-look submission.
1/26/24 - Administrative Kick Off Call
1/9/24 - Study team is working on the concept. Internal Kick Off Call 2/9/24. FNIH is planning the Administrative and Scientific Kick Off Calls.
12/22/23 - Drs. Saltos and Doroshow accepted the invitations to serve as Study Chair/Co-Chair. Dr. Edelman accepted the invitation to serve as Champion.
12/18/23 - Study Chair Welcome Letters sent
12/15/23 - Daiichi Sankyo agrees to support the study.
12/4/23 - DSC Approved
Randomized Phase III Study of Mosunetuzumab vs. Rituximab for Low Tumor Burden Follicular Lymphoma
Capsule Summary Approval Date:  
Concept or Lol submit to NCI: 02/10/2023 
Target Date: 12/05/2023 
Drop Dead Date: 08/31/2024 
Progress: 412 of 270 days

Current Status:
3/5/2024: Larry reached out. GNE has one more comment and that they have been delayed in replying to CTEP review.
2/19/2024: resubmitted to CTEP.
2/9/2024: received third round of review comments.
2/6/2024: CTEP has said to anticipate the decision this week (2/5-9). It isn't clear whether this will be an approval or further comment, last review was short. GNE contract and SDEA still in progress.
1/9/2024: Attaching the letter to the top of the protocol and linking then submitting today.
12/26/2023: CTEP sent 2nd round of review comments. Total anticipated accrual: 600.
12/5/2023: GNE fwded comments to ops on 11/28/2023, anticipating a second round of review comments shortly.
11/7/2023: Response to initial CTEP Consensus review was submitted pm 11/6/2023.
10/3/2023: Initial review comments received 10/2. Meeting with team on 10/5 to discuss. Potential meeting with Anna re: imaging budget.
9/5/2023: Submitted to CTEP for initial review on 8/22.
8/1/2023: PRC was completed on 7/5. Pending internal review before submitting to CTEP.
7/11/2023: PRC review occurred on 7/5, Rituximab drug supply conversation began on 6/20.
6/6/2023: Study will not be registrational; RaPID action items ongoing; Targeting PRC in early July.
5/2/2023: RaPID has been scheduled for 5/25, the team has turned in their edits on the first draft, GNE is still internally discussion whether or not to pursue a registration status.
3/7/2023: pending GNE's availability to schedule first Data requirement discussion. Will be looking for team's general availability for the next three weeks as well, and also look to schedule TM talks.
3/10/2023: Steering Committee review
Phase III Study of Neoadjuvant/Adjuvant Pembrolizumab versus Adjuvant Pembrolizumab in Resectable Melanoma
Capsule Summary Approval Date:  

Current Status:
2/26/24: Committee chair was given guidance from Dr. Blanke to resubmit concept to CTEP with same study number for review with a cover letter stating rational why trial should be considered.
1/22/24: Received CTEP concept disapproval. Administrative Withdrawal/Disapproved decision.
1/9/24: As of today concept does not have a review date yet.
12/ 7/23: Concept was submitted to CTEP
triage capsule approved 8/15
A Phase II Study of Targeted Agents with the Oral DNMT1 Inhibitor Cedazuridine-Decitabine (ASTX727) for the Treatment of Newly Diagnosed TP53-Mutated Acute Myeloid Leukemia in Older Patients: A myeloMATCH Treatment Trial
Capsule Summary Approval Date: 01/04/2022 
Concept or Lol submit to NCI: 01/04/2022 
Target Date: 10/01/2022 
Drop Dead Date: 11/20/2023 
Progress: 842 of 270 days

Current Status:
Formally withdrawing protocol submission April 2024.
Discussions ongoing regarding Magrolimab (FDA hold); Study under review/on hold at CTEP.
RRA rec'd 1/23/24. No action until we hear from CTEP.
myeloMATCH OEWG timelines suspended.
Consensus review rec'd 9/11. CTEP resub 9/15.
Consensus review rec'd 8/14. CTEP resub 8/28.
Consensus review rec'd 6/26. Resub week of 7/10.
Consensus review rec'd 3/30/23. Resub 4/25/23.
*Updated* consensus rec'd 2/7/23. CTEP resub 2/13/23.
Updated consensus review received 12/29/2022. CTEP resub 2/6/23.
NCI call occurred 12/19/2022.
CTEP consensus review received 11/22/2022.
CTEP submission 10/17/2022.
PRC 09/14/2022.
RaPID completed 08/29/2022.
Concept approval on hold, OEWG call 2/8/22.
LKSC: 01/04/2022
Concept submission: 11/02/2021
F&F 10/18/21.
Risk assessment 10/7/21.
Triage approval 9/27/21.

A Randomized Phase 2 trial of C-DEC, venetoclax, and enasidenib compared with azacitidine and venetoclax for newly diagnosed older adults with IDH2 mutant AML: A myeloMATCH treatment trial
Capsule Summary Approval Date: 09/23/2022 
Concept or Lol submit to NCI: 01/31/2023 
Target Date: 11/25/2023 
Drop Dead Date: 05/23/2024 
Progress: 422 of 270 days

Current Status:
NCI Teleconference scheduled for 3/5/24.
Consensus review comments received 2/6/24.
Initial CTEP Protocol submisssion 12/07/23.
Study team call 12/05.
PRC 9/20/23. Edits sent to team 9/26.
RaPID 8/8/23.
6/7/2023: LKSC concept approval
Scheduling RaPID week of 7/24.
1st draft protocol edits under review 6/6/23.
3/31/23: NCI Teleconference for concept
3/8/23: Concept approval-on-hold (awaiting drug commitments)
2/28/2023: LKSC review.
01/30/2023: LKSC submission
11/01/2022: F&F occurred.
10/06/2022: Risk Assessment Scheduled.
09/23/2022: Capsule triage approved.

A Randomized Phase II Study of Novel Therapeutics in Younger Patients with High-Risk Acute Myeloid Leukemia
Capsule Summary Approval Date: 12/08/2020 
Concept or Lol submit to NCI: 07/10/2021 
Target Date: 08/22/2021 
Drop Dead Date: 09/15/2023 
Progress: 1157 of 180 days

Current Status:
CIRB approval received: 2/13/24.
Resubmitted to CTEP 01/30/24. CIRB Amendment App 1/31.
myeloMATCH OEWG timelines suspended.
CTEP comments rec'd 01/02/24.
11/21/23 version resubmitted to CTEP 12/4/23
CIRB approval 9/19/23.
CIRB amendment app 8/29/23.
Resub to CTEP 8/22/23 (v9).
OEWG timeline extended to 9/15/2023. Extension expected.
CIRB resub 5/31/2023. CIRB approval 6/21/23. Working on company comments for CTEP.
CIRB amendment application 5/2/23.
CTEP resub 4/13/23 (with Arm 5). CTEP approval on hold 4/26/23.
Updated Schema received 01/06/2023. CTEP resub 2/21/23. Withdrawn.
New review received 12/29/2022.
CTEP approval on hold received 12/20/2022.
Waiting on final approval - pre-activation revision is pending.
CIRB re-submission due 10/05/2022.
CIRB approval received 10/14/2022
CIRB initial application due 09/7/2022.
CTEP approval on hold 09/02/022.
OEWG timeline for MATCH extended until October 2022.
CTEP resub 6/26/22.
CTEP re-submission 2/1/2022. Responses rec'd 2/24/22.
NCI Teleconference 1/10/2022.
CTEP review 12/2/21.
Protocol submitted to CTEP on 11/12/21.
PRC held on 9/22.
Post-RaPID protocol draft distributed.
RaPID held on 07/20/21.
Approved by Steering Committee 7/27/2021.
Consensus review response to concept review submitted 06/09.

Master Screening and Reassessment Protocol (MSRP) for the NCI myeloMATCH trials
Capsule Summary Approval Date: 03/03/2021 
Concept or Lol submit to NCI: 07/10/2021 
Target Date: 09/21/2021 
Drop Dead Date: 09/15/2023 
Progress: 1127 of 180 days

Current Status:
CIRB approval received: 2/7/24.
Resubmitted to CTEP 01/22/24. CIRB Amendment app 1/29.
CTEP comments rec'd 01/02/24.
MSRP/TAP resub to CTEP 12/01/23.
myeloMATCH OEWG timelines suspended.
myeloMATCH team working on TAP integration. In-person review 6/3/21.
CIRB approval 5/31/2023
CIRB amendment application submitted 5/2/23.
CTEP approval on hold 4/27/23.
Consensus rec'd 3/29/23. Resub by 4/7/23.
CTEP resub 2/21/23
Awaiting Help Desk Contact Information and OEWG timeline extension. 6/16/2023.
New review received 12/29/2022. Pathology forms received 01/06/2023.
CTEP approval on hold 12/20/2022.
Waiting on final approval - pre-activation revision is pending.
CIRB approval received 10/14/2022
CIRB initial application due 09/07/2022.
CTEP approval on hold 09/02/2022.
CTEP resub 4/26/2; 6/28/22.
CTEP re-submission 1/26. Responses received 2/25.
NCI Teleconference 1/11/22.
Protocol submitted to CTEP on 11/12/2021.
RaPID for 09/17/21. PRC held on 9/29/21.
Protocol Draft circulated to study team 04/01/21.
MSRP Concept approved 04/05/21.

NOTE: MSRP is not subject to OEWG timeline
Palliative and End of Life Care Committee
A Randomized Phase III multicenter trial of lanreotide for the prevention of postoperative pancreatic fistula
Capsule Summary Approval Date: 06/20/2023 

Current Status:
6/20/2023 Capsule approved by Exec Committee
6/29/2023 Study team working on concept.
7/28- Submitted Concept to DCP
8/21 F&F Call - scheduling separate KOC call with Cipla.
9/13 Early-Stage Investigator Workshop - Protocol Development
9/26 DCP Steering Committee Review - Outcome is "Pending".
10/12 DCP Comments received.
12/7/2023 Concept resubmitted to DCP.
1/25/24 DCP approval
3/29/24 RAPID
4/4/24 Pre-Launch Meeting in Seattle
4/15/24 Submit for PRC
5/9/24 Protocol Submission due to DCP

Distress Screening for Family Caregivers of Persons with Advanced Cancer: The FamilySTRONG Randomized Clinical Trial
Capsule Summary Approval Date:  

Current Status:
8/25 Mini F&F Call.
9/12 Triage approved. Assigned SWOG number S2418.
10/15 R01 Submitted by Dr. Odom's Institution.
2/26/24 The R01 score was good but study is not fundable. The study team is discussing next steps.
Telehealth Intervention for personalized Self-Management (TIPS) for Eating after Gastroesophageal Cancer Surgery
Capsule Summary Approval Date: 01/22/2024 

Current Status:
01/22/2024 Triage approval received.
02/05/2024 R01 submitted.
Multi-Arm Phase II Trial Comparing Standard of Care Chemotherapy to Subtype-Directed Therapy in Predicting Response of Muscle Invasive Bladder Cancer (SUBTYP)
Capsule Summary Approval Date:  

Current Status:
3/5: As of today, have not heard anything back yet.
2/22: During scientific call with GNE and Tempus, it was hinted that GNE will be conducting an internal review of the study as part of their internal budgeting process. Said they were presenting on Monday (2/26).
Phase I/II Study of Amivantamab carboPlatin and pacliTaxel in recurrent metastatic Head and Neck cancer (APT-HN) Study Synopsis
Capsule Summary Approval Date: 12/01/2022 

Current Status:
03/05/24: No new updates. Pending contract execution before protocol development.
02/06/24: Pending contract execution before protocol development.
01/09/24: Pending contract execution before protocol development.
12/01/22: Capsule approved by ERC.
A Phase II Trial of Asciminib, Dasatinib, Prednisone, and Blinatumomab for Patients with Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Acute Lymphoblastic Leukemia
Capsule Summary Approval Date: 02/20/2023 

Current Status:
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

Symptom Control and Quality of Life
Emerging from the Haze (Haze)- A multi-dimensional, psycho-educational, cognitive rehabilitation program to improve perceived cognitive function for cancer survivors [Planning Grant (U34)]
Capsule Summary Approval Date: 01/15/2020 

Current Status:
1/15/20 - Exec. Committee/Triage approved
6/21/23 - U34 Submission
2/14/24 - U34 Resubmission

Acupuncture to decrease symptom burden in patients with metastatic breast cancer
Capsule Summary Approval Date: 09/11/2023 

Current Status:
8/16/23 - Stats PRC
9/11/23 - Triage as FYI
10/5/23 - R01 Submission
June 2024 Resubmission

R01 was reviewed on 2/12/24 (Impact score: 42, percentile: 44.0) and will be resubmitted in June 2024.