Inclusion Criteria:
-Participants and Target Disease Characteristics- -
- Confirmed disease progression by RECIST 1.1 criteria on nivolumab maintenance after
induction with ipilimumab and nivolumab
- Progress of maintenance treatment of nivolumab by RECIST. Pathology report must be
submitted for embedded tissue block or tumor tissue.
Age and Reproduction Sexually active males with WOCBP must agree to instructions for
contraception and fetal protection.
WOCBP need to use contraception throughout the study and for 5 months post treatment.
Exclusion Criteria autoimmune disease statement
- Active central nervous system metastases
- Participants with an active autoimmune disease, diabetes mellitus, skin disorders,
hyperthyroidism requiring hormone treatments are permitted to enroll.
- Any major surgery 28 days before 1st treatment Concomitant Therapy
- participants that have received a live vaccine within 30 days of treatment.
- use of investigational agent or device with in 28 days before first dosage study
treatment.
Physical and Laboratory Test Findings Allergies and Adverse Drug Reaction Age and
Reproduction
