Head and Neck Cancer
A Phase Ib, open-label, multicenter study designed to assess the safety, tolerability, and pharmacokinetics of coadministration of MPDL3280A and of cobimetinib in patients with metastatic or locally advanced cancer for which no standard of care exists.
- Age >/= 18 years.
- Solid tumor that is metastatic, locally advanced or recurrent.
- ECOG performance status of 0 or 1.
- Life expectancy >/= 12 weeks.
- Measurable disease, as defined by RECIST v1.1.
- Adequate blood and organ function.
- Use of highly effective contraception.
- Histological tumor tissue specimen.
- Patients enrolling in the expansion cohorts in Stage 2 must consent to tumor biopsies and must have one of the following types of cancer:
- KRAS-mutant metatastic colorectal cancer (mCRC)
- Non-small cell lung cancer (NSCLC)
- Pregnant and lactating women.
- History of autoimmune disease.
- Patients with prior stem cell or organ transplant.
- History of idiopathic pulmonary fibrosis.
- History of HIV or hepatitis C infection; history of hepatitis B is allowed if infection has resolved (absence of HBsAG).
- Severe infections within 4 weeks prior to study start; signs or symptoms of infection within 2 weeks prior to study start.
- Oral or IV antibiotic therapy within 2 weeks prior to study start.
- Significant cardiovascular disease.
- Administration of a live, attenuated vaccine within 4 weeks before study start or until the end of the study.
- Any approved anti-cancer therapy, including chemotherapy or hormonal therapy, within 3 weeks prior to study start.
- Active or untreated central nervous system (CNS) tumors.
- Leptomeningeal disease.
- Excess, uncontrolled calcium levels.
- History of prior significant toxicity from another MEK pathway inhibitor requiring discontinuation of treatment.
- Prior treatment with CD137 agonists or immune checkpoint blockade therapies.
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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