Clinical trial NCT05405413: CAncer TReatment INformed by the Molecular Tumor Board At Dartmouth
Official title: CAncer TReatment INformed by the Molecular Tumor Board At Dartmouth
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Cancer
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2022-06-06
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Proportion of subjects for whom evaluation by Molecular Tumor Board impacts treatment decisions as reported by the treating physician.
timeFrame: 3 months after recommendation
measure: Proportion of subjects for whom evaluation by Molecular Tumor Board impacts treatment decisions as reported by the treating physician.
timeFrame: 12 months after recommendation
Secondary outcomes:
measure: Proportion of subjects for whom Molecular Tumor Board recommends treatment with a tumor-targeted therapy or immunotherapy.
timeFrame: 1 month after recommendation
measure: Proportion of subjects who are treated with a Molecular Tumor Board-recommended tumor-targeted therapy or immunotherapy
timeFrame: Approximately 3 months after recommendation
measure: Number of participants with progression-free survival after Molecular Tumor Board recommendations were made.
timeFrame: Up to 36 months after recommendation
measure: Time to treatment failure
timeFrame: Up to 36 months after recommendation
measure: Proportion of subjects for whom Molecular Tumor Board-recommended germline genetic testing results in confirmation of a germline genetic lesion/mutation.
timeFrame: Approximately 3 months after recommendation
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
References: