Cancer
Conditions
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.
Interventions
OTHERTreatment 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
Sponsors
Dartmouth-Hitchcock Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects for whom evaluation by Molecular Tumor Board impacts treatment decisions as reported by the treating physician. | 3 months after recommendation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects for whom Molecular Tumor Board recommends treatment with a tumor-targeted therapy or immunotherapy. | 1 month after recommendation | Proportion of subjects for whom a tumor-targeted therapy or immunotherapy (i.e., not conventional chemotherapy) made by the Molecular Tumor Board will be collected. |
| Proportion of subjects who are treated with a Molecular Tumor Board-recommended tumor-targeted therapy or immunotherapy | Approximately 3 months after recommendation | Proportion of subjects who are treated with a Molecular Tumor Board-recommended tumor-targeted therapy or immunotherapy |
| Number of participants with progression-free survival after Molecular Tumor Board recommendations were made. | Up to 36 months after recommendation | Subjects' disease outcomes will be followed for up to 36 months following the date of Molecular Tumor Board recommendations. Progression-free survival is defined as the time from start of treatment to disease progression or death from any cause. |
| Time to treatment failure | Up to 36 months after recommendation | Time to treatment failure is defined as the time from start of treatment to discontinuation of treatment for any reason, including disease progression, treatment toxicity, and death. |
| 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 | Determine the proportion of subjects for whom Molecular Tumor Board-recommended germline genetic testing results in confirmation of a germline genetic lesion/mutation. |
Countries
United States
Contacts
Primary ContactLaura J Tafe, MD
Backup ContactJacob R Dubien
Outcome results
None listed