CAncer TReatment INformed by the Molecular Tumor Board At Dartmouth

NCT05405413 | Recruiting Phase 2 DMC

• 3 other identifiers: STUDY02001441NCI-2024-0340422TAF441
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-arm Phase II study to measure the impact of Molecular Tumor Board treatment recommendations on treatment decision-making in clinical practice at the Dartmouth Cancer Center. Following tumor genetic profiling, subjects will be screened for eligibility. Eligible subjects' cases will be evaluated by the Dartmouth Cancer Center Molecular Tumor Board, and treatment recommendations will be entered into the medical record as per standard procedure. The primary endpoint is a survey response from the treating physician indicating how Molecular Tumor Board evaluation impacted treatment decisions. Secondary endpoints include: 1) Molecular Tumor Board treatment recommendation; 2) disease progression on line of therapy started after MTB recommendations were made. Surveys will be administered approximately 3 and 12 months after Molecular Tumor Board recommendations are made.

Conditions

Cancer

Outcome Measures

Primary Outcomes (2)

• Proportion of subjects for whom evaluation by Molecular Tumor Board impacts treatment decisions as reported by the treating physician.

  Treating physicians will complete surveys at 3 months after Molecular Tumor Board recommendations are made. Survey response from the treating physician indicating how Molecular Tumor Board recommendations impacted treatment decisions.

  3 months after recommendation

• Proportion of subjects for whom evaluation by Molecular Tumor Board impacts treatment decisions as reported by the treating physician.

  Treating physicians will complete surveys at 12 months after Molecular Tumor Board recommendations are made. Survey response from the treating physician indicating how Molecular Tumor Board recommendations impacted treatment decisions.

  12 months after recommendation

Secondary Outcomes (5)

• Proportion of subjects for whom Molecular Tumor Board recommends treatment with a tumor-targeted therapy or immunotherapy.

  1 month after recommendation

• Proportion of subjects who are treated with a Molecular Tumor Board-recommended tumor-targeted therapy or immunotherapy

  Approximately 3 months after recommendation

• Number of participants with progression-free survival after Molecular Tumor Board recommendations were made.

  Up to 36 months after recommendation

• Time to treatment failure

  Up to 36 months after recommendation

• Proportion of subjects for whom Molecular Tumor Board-recommended germline genetic testing results in confirmation of a germline genetic lesion/mutation.

  Approximately 3 months after recommendation

Study Arms (1)

Subjects evaluated by Molecular Tumor Board

EXPERIMENTAL

Subjects whose cases are evaluated by Molecular Tumor Board

Other: Treatment recommendations made by Molecular Tumor Board.

Interventions

Treatment recommendations made by Molecular Tumor Board. OTHER

Molecular Tumor Board recommendations may include any of the following: (A) a tumor-targeted drug (alone or in combination) (B) an antibody-based immunotherapy (alone or in combination) (C) neither (A) nor (B). (D) referral to the Familial Cancer Program (E) referral for germline genetic testing

Subjects evaluated by Molecular Tumor Board

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must provide verbal informed consent for study participation prior to MTB case evaluation.
• Tumor genetic profiling performed as standard of care must include ≥100 genes.
• Tumor must contain at least one of the following genetic alterations: (A) an alteration known to be potentially associated with sensitization to a clinically available treatment. (the list of genetic alterations evolves as new information emerges and new drugs are developed); (B) an alteration suspected to be germline.
• Subject must have ECOG Performance Status of 0 to 2.
• Subject must have measurable or evaluable disease.
• Subjects who have previously enrolled in this study can be enrolled a second time if they undergo genetic profiling of a tumor that was biopsied/sampled AFTER progression on an intervening line of treatment started after the time of first enrollment. Re-enrollment of such subjects must be noted in REDCap to facilitate longitudinal analysis.
• Age ≥18 years.

You may not qualify if:

• Pregnant women.

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Laura J Tafe, MD

CONTACT

(603) 650-7211; laura.j.tafe@hitchcock.org

Jacob R Dubien

CONTACT

jacob.r.dubien@Hitchcock.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator; Associate Professor, Department of Pathology & Laboratory Medicine

Study Record Dates

• First Submitted: May 27, 2022
• First Posted: June 6, 2022
• Study Start: March 19, 2024
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)