New drug duo aims to fight rare melanoma before surgery
NCT ID NCT07517653
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase II trial tests two drugs—SHR-1701 (an immunotherapy) and famitinib (which cuts off tumor blood supply)—given before surgery for resectable mucosal melanoma, a rare and aggressive skin cancer. After surgery, treatment is tailored based on how well the tumor responded. The study will enroll 70 adults to see if this approach improves event-free survival and overall outcomes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SHR-1701 (an immunotherapy drug) and famitinib (a drug that blocks blood vessel growth)
- What this could lead to
- If successful, this combination could become a new standard treatment before and after surgery for mucosal melanoma, potentially improving survival and reducing recurrence.
- What could go wrong
- This is an early phase II trial with only 70 participants, so results may not apply to all patients. The combination may cause significant side effects, and it is not yet known if it will improve long-term outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 70 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age ≥ 18 years and ≤ 75 years, regardless of sex. * Histopathologically confirmed mucosal melanoma. * Focal, lymph node metastatic, or oligometastatic mucosal melanoma assessed as completely resectable by multidisciplinary team (surgery/ENT/gynecology/colorectal, radiotherapy, oncology, imaging/pathology, etc.). * ECOG Performance Status of 0 or 1. * Life expectancy ≥ 12 weeks. Exclusion Criteria: * Prior treatment with PD-1/PD-L1 antibodies or anti-angiogenic agents. * Ocular melanoma or melanoma of unknown primary site. * History of immunodeficiency, acquired or congenital immune deficiency diseases, or organ transplantation. * Pregnant or breastfeeding women. * Abnormal coagulation function (APTT \> 43 seconds or INR \> 1.5 × ULN), or history of bleeding tendency or bleeding events (e.g., gastrointestinal bleeding, gastric ulcer bleeding) within 3 months before enrollment.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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Other studies related to the condition(s) this trial covers.
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- Laser microscope may speed up skin cancer diagnosis