Cancer treatment guided by a Molecular Tumor Board at Dartmouth

CAncer TReatment INformed by the Molecular Tumor Board At Dartmouth

This study is testing if treatment suggestions from a special group of experts can help doctors make better choices for cancer patients at Dartmouth Cancer Center.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 192 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Dartmouth-Hitchcock Medical Center (other)
• Locations: 1 site (Lebanon, New Hampshire)
• Trial ID: NCT05405413 on ClinicalTrials.gov

What this trial studies

This Phase II interventional study evaluates how treatment recommendations from a Molecular Tumor Board influence clinical decision-making for cancer patients at the Dartmouth Cancer Center. After genetic profiling of tumors, eligible patients will have their cases reviewed by the board, which will provide treatment recommendations documented in their medical records. The primary goal is to assess the impact of these recommendations on physician treatment choices through surveys conducted at 3 and 12 months post-recommendation. Secondary outcomes include tracking disease progression following the recommended treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with measurable or evaluable cancer who have undergone tumor genetic profiling and have specific genetic alterations.

Not a fit: Patients without measurable disease or those whose tumors do not have the required genetic alterations may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more personalized and effective cancer treatments based on genetic profiling.

How similar studies have performed: Other studies have shown promise in using molecular tumor boards to guide treatment decisions, indicating a growing interest in this approach.

Eligibility criteria

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.

Where this trial is running

Lebanon, New Hampshire

• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States (RECRUITING)

Study contacts

• Study coordinator: Laura J Tafe, MD

Conditions: Cancer