New drug duo aims to fight rare melanoma before surgery

NCT ID NCT07517653

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 70 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

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

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

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  1. The official record

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