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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

Interventions

Anti-OX40
Ipilimumab

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:

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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