Spots Global Cancer Trial Database for Study of the Combination of Anti-OX40 and Ipilimumab in Patients With Metastatic Melanoma
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Trial Identification
Brief Title: Study of the Combination of Anti-OX40 and Ipilimumab in Patients With Metastatic Melanoma
Official Title: Phase 1/2 Study of the Combination of a Mouse Monoclonal Antibody to OX40 and Ipilimumab in Patients With Metastatic Melanoma
Study ID: NCT01689870
Conditions
Study Description
Brief Summary: This is an open label, two-phase study combining a dose escalation Phase 1 with a proof-of-concept Phase 2 in patients with unresectable or metastatic melanoma, for whom treatment with ipilimumab is indicated. The purpose of the Phase 1 is to determine the Anti-OX40 Maximum Tolerated Dose (MTD) and the secondary objectives are anti-OX40 pharmacokinetics, biological activity and the tumor response assessed by the Immune-related Response Criteria. The purpose of Phase 2 is to determine tumor response (by irRC) and the secondary objectives are anti-OX40 pharmacokinetics, biological activity and Safety/Tolerability.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Contact Details
Name: Jedd Wolchok, MD, PhD
Affiliation: Memorial Sloan Kettering Cancer Center
Role: PRINCIPAL_INVESTIGATOR
Name: Brendan D Curti, MD
Affiliation: Providence Health & Services
Role: PRINCIPAL_INVESTIGATOR
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