CAncer TReatment INformed by the Molecular Tumor Board At Dartmouth

Обзор

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.

Вмешательства

• Другое 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

Первичные конечные точки

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

Вторичные конечные точки (5)

• Proportion of subjects for whom Molecular Tumor Board recommends treatment with a tumor-targeted therapy or immunotherapy. [Срок оценки: 1 month after recommendation]
• Proportion of subjects who are treated with a Molecular Tumor Board-recommended tumor-targeted therapy or immunotherapy [Срок оценки: Approximately 3 months after recommendation]
• Number of participants with progression-free survival after Molecular Tumor Board recommendations were made. [Срок оценки: Up to 36 months after recommendation]
• Time to treatment failure [Срок оценки: 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. [Срок оценки: Approximately 3 months after recommendation]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Dartmouth-Hitchcock Medical Center — Lebanon

Идентификаторы

NCT: NCT05405413 · STUDY02001441 · NCI-2024-03404 · 22TAF441

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗