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NCT05116202 · ClinicalTrials.gov registry record · Phase 1
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Melanoma (Morpheus-Melanoma)
A Phase 1 study of Melanoma, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 110
- Enrollment target
- 14
- Study locations
NCT05116202: Completed Phase 1 study of Melanoma, sponsored by Hoffmann-La Roche.
NCT05116202 is a Phase 1 study of Melanoma that has completed, run by Hoffmann-La Roche. The registered enrollment target is 110 participants, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (84% lower). The trial reports 14 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05116202, a Phase 1 study of Melanoma, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 110 participants
- Enrollment target
- 14
- Study locations
Study Summary
This study will evaluate the efficacy, safety, and pharmacokinetics of treatment combinations in cancer immunotherapy (CIT)-naive participants with resectable Stage III melanoma (Cohort 1) and in participants with Stage IV melanoma (Cohort 2). The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, and modify the participant population.
Primary Outcome
pRR was defined as the percentage of participants with pathologic complete response (pCR), pathologic near complete response (pnCR), and pathologic partial response (pPR) as determined by an independent pathologic review. pCR was defined as a complete absence of viable tumor cells, pnCR as \> 0 to ≤ 10% of viable tumor cells, and pPR was defined as \> 10 to ≤ 50% of viable tumor cells in the dissected lymph node. Participants with missing or no pathologic response assessment, including participa
Conditions Studied
Interventions
- DRUG Atezolizumab
- DRUG Nivolumab
- DRUG Ipilimumab
- DRUG Tiragolumab
- DRUG RO7247669 2100 mg
Study Locations (14)
Other
- Hopital de la Timone - Marseille
- APHP - Hospital Saint Louis - Paris
- Institut Universitaire du Cancer de Toulouse-Oncopole - Toulouse
- Institut Gustave Roussy - Villejuif
- Hospital Universitario Vall d Hebron - Barcelona
California
- City of Hope - Duarte
- The Angeles Clinic and Research Institute - W LA Office - Los Angeles
Florida
- Moffitt Cancer Center - Tampa
Texas
- MD Anderson Cancer Center - Houston
New South Wales
- Melanoma Institute Australia - North Sydney
Abruzzo
- Azienda Ospedaliera Universitaria Senese - Siena
Campania
- Istituto Nazionale Tumori Fondazione G. Pascale - Naples
Lombardy
- Istituto Europeo Di Oncologia - Milan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2022-02-02 |
| Est. Completion | 2024-05-28 |
| Phase | Phase 1 |
What the finished NCT05116202 record still lists
NCT05116202 is an interventional study that assigns participants to a tested intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (84% lower).
The record links to 1 condition, with Melanoma appearing as the primary indexed condition, and to 5 interventions - of which Atezolizumab is the first listed.
NCT05116202 lists 14 locations in 9 states (Other, California, Florida).
Frequently Asked Questions
What is clinical trial NCT05116202 about?
NCT05116202 is a clinical study titled "A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Melanoma (Morpheus-Melanoma)". This study will evaluate the efficacy, safety, and pharmacokinetics of treatment combinations in cancer immunotherapy (CIT)-naive participants with resectable Stage III melanoma (Cohort 1) and in participants with Stage IV melanoma (Cohort 2). The study is designed with the flexibility to open new t...
What is the current status of trial NCT05116202?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 110 participants. The study started on 2022-02-02. Estimated completion is 2024-05-28.
What conditions does trial NCT05116202 study?
This clinical trial studies the following conditions: Melanoma.
What interventions are being tested in trial NCT05116202?
The interventions under investigation include: Atezolizumab (DRUG), Nivolumab (DRUG), Ipilimumab (DRUG), Tiragolumab (DRUG), RO7247669 2100 mg (DRUG).
Who is sponsoring clinical trial NCT05116202?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05116202 being conducted?
This trial has 14 study locations across California, Florida, Texas, New South Wales, Abruzzo. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05116202's enrollment target sits among peer trials
110 106th of 266 higher than 160 of 266 other Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Melanoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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