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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
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,

Eligibility Criteria

Inclusion Criteria: 1. Histologically- or cytologically-confirmed ovarian cancer, colorectal cancer, non-triple negative breast cancer, renal cell carcinoma and cervical cancer, with at least one lesion measurable by irRC not previously irradiated. 2. Failed to respond to or relapsed following standard treatment, or declined or was not eligible for standard treatment. 3. ECOG performance status of 0-2. 4. Anticipated lifespan greater than 6 month. 5. At the time of day 1 of the study, subjects with brain metastases must be asymptomatic for at least 4 weeks and: - at least 8 weeks without tumor progression after any whole brain radiotherapy - at least 4 weeks since craniotomy and resection or stereotactic radiosurgery - at least 3 weeks without new brain metastases as evidenced by MRI/CT 6. Adequate organ and marrow function , as defined below: - Hemoglobin ≥ 9 g/dL - Absolute Neutrophil Count ≥ 1500/mm3 - Platelet count ≥ 100,000/mm3 - Total bilirubin within normal ranges unless associated with hepatobiliary metastases or Gilbert syndrome, then total bilirubin ≤ 2 x ULN - Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN unless associated with hepatic metastases, then ALT and AST ≤ 5 x ULN - Creatinine ≤ 2.0 mg/dL 7. Have been informed of other treatment options. 8. Age ≥18 years. 9. Able and willing to give valid written informed consent. 10. Able and willing to give valid written consent for archival tumor samples 11. Able and willing to give valid written consent for biopsy samples (subjects in the expansion phase only). Exclusion Criteria: 1. Prior exposure to tremelimumab or MEDI4736 or other anti-CTLA-4, anti-PD-1, anti-PDL1 antibodies 2. History of severe allergic reactions to any unknown allergens or any components of the study drugs. 3. Active or prior autoimmune disease except for autoimmune thyroiditis or vitiligo. 4. Any prior Grade ≥ 3 immune-related adverse event (irAE) or any prior corticosteroid-refractory irAE. 5. Known active or chronic viral hepatitis or history of any type of hepatitis within the last 6 months. 6. History of sarcoidosis syndrome. 7. 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. 8. Metastatic disease to the central nervous system for which other therapeutic options, including radiotherapy, may be available. 9. Known immunodeficiency or active HIV. 10. Other active serious illnesses (e.g., serious infections requiring antibiotics). 11. If a subject previously received investigational treatment, the last dose of investigational treatment was administered within 4 weeks of Day 1 of the study or adverse event(s) attributable to investigational treatment have not resolved to Grade 1 or better. 12. Major surgical procedure (as defined by the investigator) within 30 days prior to Day 1 or still recovering from prior surgery. 13. Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study. 14. Lack of availability for immunological and clinical follow-up assessments. 15. Women who are breast feeding or pregnant as evidenced by positive serum pregnancy test. 16. Females of childbearing potential who are sexually active with a nonsterilized male partner must use 2 methods of effective contraception from screening, and must agree to continue using such precautions for 6 months after the final dose of investigational product; cessation of birth control after this point should be discussed with a responsible physician. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Females of childbearing potential are defined as those who are not surgically sterile (i.e., bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or postmenopausal (defined as 12 months with no menses without an alternative medical cause). Nonsterilized males who are sexually active with a female partner of childbearing potential must use 2 acceptable methods of effective contraception from Day 1 and for 6 months after receipt of the final dose of investigational product. 17. Any condition that, in the clinical judgment of the treating physician, is likely to prevent the subject from complying with any aspect of the protocol or that may put the subject at unacceptable risk.
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