Recruiting
Phase 2

Cancer Treatment

Sponsor:

Dartmouth-Hitchcock Medical Center

Code:

NCT05405413

Conditions

Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Treatment recommendations made by Molecular Tumor Board.

Study Details

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

Study ID

NCT05405413

Start date

Mar 19, 2024

Status verified date

Oct, 2025

Completion date

Dec, 2029

Anticipated

Primary completion date

May, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Subjects with a tumor harboring a genetic alteration for which an FDA-approved drug is indicated that the patient has not yet received (example for exclusion: a melanoma with a BRAF-V600E mutation in a subject who has not yet been treated with a BRAF inhibitor).
  • Pregnant women.

Study Design

Enrollment

192 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Subjects evaluated by Molecular Tumor Board

Subjects whose cases are evaluated by Molecular Tumor Board

Interventions

Treatment recommendations made by Molecular Tumor Board.

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

Primary outcome measure

  • Proportion of subjects for whom evaluation by Molecular Tumor Board impacts treatment decisions as reported by the treating physician. [ Time Frame: 3 months after recommendation ]
  • Proportion of subjects for whom evaluation by Molecular Tumor Board impacts treatment decisions as reported by the treating physician. [ Time Frame: 12 months after recommendation ]

Central Contacts and Locations

Central contacts

Laura J Tafe, MD

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

Jacob R Dubien

jacob.r.dubien@Hitchcock.org

Locations

Dartmouth-Hitchcock Medical Center

Recruiting

Lebanon, New Hampshire, United States, 03756

More Information

Sponsor

Dartmouth-Hitchcock Medical Center

Last update posted

Oct 20, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dartmouth-Hitchcock Medical Center on 2025-10-20.