Time-of-Day Specified Immunotherapy for Advanced Melanoma, The TIME Trial
Recruiting
Phase 2
Interventional Study
Advanced Acral Melanoma
Advanced Cutaneous Melanoma
Advanced Mucosal Melanoma
Clinical Stage IV Cutaneous Melanoma AJCC v8
Metastatic Acral Melanoma
Metastatic Cutaneous Melanoma
Metastatic Mucosal Melanoma
Unresectable Acral Melanoma
Unresectable Cutaneous Melanoma
Unresectable Mucosal Melanoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 99 (estimated)
- Sponsor
- Emory University · Other
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About This Trial
This phase II trial tests the safety and effectiveness of giving ipilimumab and nivolumab in the morning compared to other times of day in treating patients with melanoma that is stage IV or that cannot be removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the tumor and may interfere with the abili…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Pathologically confirmed American Joint Committee on Cancer (AJCC) 8th edition stage IV unresectable cutaneous, acral, or mucosal melanoma
* No uveal melanoma
* Patients with asymptomatic, non-hemorrhagic brain metastases \< 2 cm are eligible
* No prior immunotherapy within 1 …
Contacts