Neoadjuvant SHR-1701 Plus Famitinib With Response-guided Adjuvant Therapy in Resectable Mucosal Melanoma

NCT07517653 | Not Yet Recruiting Phase 2

• 1 other identifier: B2026-002
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to investigate the efficacy and safety of SHR-1701 in combination with famitinib in the perioperative treatment of mucosal melanoma

Conditions

Melanoma

Outcome Measures

Primary Outcomes (1)

• Event-Free Survival, EFS

  From start of treatment to end of study, up to approximately 36 months

Secondary Outcomes (7)

• Overall Survival (OS)

  From start of treatment to end of study, up to approximately 36 months

• Major Pathological Response (MPR)

  Perioperative

• Recurrence-Free Survival (RFS)

  From surgery to end of study, up to ~36 months

• Pathological Response Rate (pRR)

  Perioperative

• Objective Response Rate (ORR)

  Perioperative

Study Arms (1)

SHR-1701 + Famitinib

EXPERIMENTAL

Drug: SHR-1701; Drug: Famitinib

Interventions

SHR-1701 DRUG

Specifically targets mucosal melanoma, which accounts for 22.6% of melanoma cases in China

SHR-1701 + Famitinib

Famitinib DRUG

Specifically targets mucosal melanoma, which accounts for 22.6% of melanoma cases in China

SHR-1701 + Famitinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

MeSH Terms

Conditions

Melanoma

Interventions

SHR-1701; famitinib

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2026
• First Posted: April 8, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: April 8, 2026

Record last verified: 2026-03