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Clinical Observation on the Safety and Efficacy of Cardonilmab in the Treatment of Second-line and Above Advanced Melanoma and Advanced Renal Cancer

NCT06670300 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-11-01

No results posted yet for this study

Summary

Safety and efficacy of Cardonilmab as a second-line or above treatment in patients with advanced malignant melanoma and renal cell carcinoma.

To investigate the safety and efficacy of cardunnilizumab in the treatment of advanced mucosal, acral and cutaneous malignant melanoma and advanced renal cell carcinoma.

Primary end point: objective response rate (ORR) Secondary end point: progression-free survival (PFS), disease control rate (DCR), overall survival (OS), incidence of treatment-related adverse events Exploratory study end point: efficacy related marker exploration, gut microbiota or metabolomics changes

Conditions

  • Participants Who Had Received Second-line or Higher Advanced Melanoma and Advanced Renal Cancer

Interventions

DRUG

cardonilimab

Subjects will receive cardonilimab 10mg/kg once every three weeks; The maximum duration of administration is 2 years until disease progression or death, toxicity becomes intolerable, subject voluntarily requests withdrawal, or investigator determines that subject needs to withdraw from the study.

Sponsors & Collaborators

  • YongZhang

    lead OTHER_GOV

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-12-01
Primary Completion
2027-12-30
Completion
2027-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06670300 on ClinicalTrials.gov