A Phase 1 Study to Evaluate MEDI4736 in Combination With Tremelimumab

Status: Recruiting
Diagnosis: Solid Tumor/Phase I
NCT ID: NCT01975831 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 13-378


This is a multicenter, open-label, study with a standard 3+3 dose-escalation phase, followed by an expansion phase in subjects with solid tumors


Conducting Institutions:
Brigham and Women's Hospital, Dana-Farber Cancer Institute

Overall PI:
Patrick Ott, MD, Dana Farber Cancer Institute

Site-responsible Investigators:

Dana-Farber Cancer Institute: Meghara Walsh, 617-632-5264, mwalsh10@partners.org

Eligibility Criteria

Inclusion Criteria: - Histologically- or cytologically-confirmed solid tumor with at least one measurable lesion. - Failed to respond to or relapsed following standard treatment, or declined or was not eligible for standard treatment. - ECOG performance status of 0-2. - Anticipated lifespan greater than 6 month. - Adequate organ and marrow function - Able and willing to give valid written informed consent. - Able and willing to give valid written consent for archival tumor samples - Able and willing to give valid written consent for biopsy samples (subjects in the expansion phase only). Exclusion Criteria: - Prior exposure to Tremelimumab or MEDI4736 or other anti-CTLA-4, anti-PD-1, anti-PD-L1 antibodies - History of severe allergic reactions to any unknown allergens. - Active or prior autoimmune disease except for autoimmune thyroiditis or vitiligo. - Any prior Grade ≥ 3 immune-related adverse event (irAE) or any prior corticosteroid-refractory irAE. - Known active or chronic viral hepatitis or history of any type of hepatitis within the last 6 months. - History of sarcoidosis syndrome. - Active or history of inflammatory bowel disease (colitis, Crohn's), diverticulitis, irritable bowel disease, celiac disease, or other serious, chronic, gastrointestinal conditions associated with diarrhea. Active or history of systemic lupus erythematosus or Wegener's granulomatosis. - Metastatic disease to the central nervous system for which other therapeutic options, including radiotherapy, may be available. - Known immunodeficiency or active HIV. - Participation in any other clinical trial involving another investigational agent within 4 weeks prior to day 1 of the study. - Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study. - Women who are breast feeding or pregnant - Women of childbearing potential not using a medically acceptable means of contraception for the duration of the study.
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