Comparing Tunlametinib Capsules and Combination Chemotherapy in Advanced NRAS-mutant Melanoma
Recruiting
Phase 3
Interventional Study
Melanoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
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 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 165 (estimated)
- Sponsor
- Shanghai Kechow Pharma, Inc. · Industry
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About This Trial
This is a multicenter, two-arm, open-label, randomized controlled phase III clinical trial to evaluate the efficacy and safety of tunlametinib capsule in comparison with the combination chemotherapy of investigator's choice in advanced melanoma patients with NRAS mutation who have received immunotherapy before. Subjects were stratified according to the baseline lactate dehydrogenase level and chem…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. ≥ 18 years of age.
2. Patients with unresectable stage III or metastatic IV melanoma confirmed by histology or cytology.
3. History of immunotherapy failure or could not tolerate immunotherapy
4. NRAS mutation at baseline;.
5. There is at least one lesion that can be evaluate…
Contacts