Study of Ipilimumab, Nivolumab, and Cabozantinib in Patients With Cutaneous Melanoma
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- STATUS
- Recruiting
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- End date
- Jun 27, 2031
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- participants needed
- 41
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- sponsor
- Providence Health & Services
Summary
The primary objective of this clinical trial is to evaluate the clinical efficacy and progression free survival of the triplet combination of ipilimumab + nivolumab + cabozantinib in patients with anti-PD-1/PD-L1 refractory metastatic cutaneous melanoma.
Description
This is a phase II, single arm, single institution clinical trial. Eligible adults with anti-PD-1 refractory, unresectable/metastatic cutaneous melanoma will be treated with the triplet combination of ipilimumab 1 mg/kg + nivolumab 3 mg/kg every 3 weeks for 4 cycles in addition to cabozantinib 40 mg/day. For cycles 5+, treatment will consist of nivolumab 480 mg IV every 4 weeks in combination with cabozantinib 40 mg/day. The total duration of therapy will be 24 months or until either disease progression or the occurrence of unacceptable drug-related toxicity. Regular tumor assessments should be performed to determine if PD is present.
Details
| Condition | Refractory Cutaneous Melanoma |
|---|---|
| Treatment | Ipilimumab, Nivolumab, Cabozantinib |
| Clinical Study Identifier | NCT05200143 |
| Sponsor | Providence Health & Services |
| Last Modified on | 27 June 2022 |
Eligibility
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