Phase I/II Dose Escalation of Varlilumab and Nivolumab
A Phase I/II Dose Escalation and Cohort Expansion Study of the Safety, Tolerability and Efficacy of Anti-CD27 Antibody (Varlilumab) Administered in Combination with Anti-PD-1 (Nivolumab) in Advanced Refractory Solid Tumors
The primary purpose of this research study is to test the effectiveness (how well the drug works), safety, and tolerability varlilumab and nivolumab (investigational drugs) together. Varlilumab and nivolumab are antibodies (types of human protein) that are manufactured in a laboratory and are being tested to see if they will allow the body’s immune system to work against tumor cells. This is the first time varlilumab and nivolumab have been tested together in humans. Using similar agents in cancer models in mice showed that combining the treatments worked better than either treatment alone.
Are you Eligible? (Inclusion Criteria)
1. Advanced (unresectable and/or metastatic) histologically-diagnosed NSCLC; MEL, CRC, SCCHN, or ovarian cancer.
2. No more than 3 prior anticancer regimens for advanced (recurrent, locally advanced or metastatic) disease.
3. Documented progressive disease, based on radiographic, clinical or pathologic assessment, at study entry.
4. All residual toxicity (excluding vitiligo, endocrinopathies on stable replacement therapy,alopecia, grade 2 fatigue, grade 2 neuropathy from taxanes or platinum and grade 2 hearing loss from platinum) related to prior anticancer therapies must resolve to grade 1 severity or less (or returned to baseline) prior to receipt of study treatment.
5. Measurable (target) disease by RECIST 1.1 criteria (Eisenhauer, Therasse et al. 2009)
Target lesions selected for tumor measurements should be those where additional treatments are not indicated or anticipated.