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Spots Global Cancer Trial Database for Sitravatinib With or Without Tislelizumab in Patients With Unresectable or Metastatic Melanoma

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Trial Identification

Brief Title: Sitravatinib With or Without Tislelizumab in Patients With Unresectable or Metastatic Melanoma

Official Title: A Phase II Study Exploring the Safety, Tolerability and Preliminary Anti-tumor Activity of Sitravatinib With or Without Tislelizumab in Patients With Unresectable or Metastatic Melanoma

Study ID: NCT05104801

Conditions

Melanoma

Study Description

Brief Summary: In 2014, an estimated 7,000 patients were diagnosed of melanoma in China. It is growing at an annual rate of 3%-5% and approximately 20,000 new cases are reported each year recently.To date, CFDA only approved dacarbazine as first line chemotherapy and anti-PD-1 antibody monotherapy as second line. There is no standard of care after chemotherapy and anti-PD-1.

Detailed Description: This is an open-label, randomized, single center phase 2 study evaluating the efficacy and safety of sitravatinib in combination with tislelizumab for Chinese patients with unresectable or metastatic melanoma after disease progression from prior anti-PD-1 antibody and chemotherapy. The first 20 patients will be randomized in a 1:1 ratio to receive either sitravatinib plus tislelizumab (Arm A) or sitravatinb monotherapy (Arm B). After the completion of initial 20 patients, additional patients will be recruited until 24 efficacy evaluable patients achieved in Arm A

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Beijing Cancer Hospital, Beijing, Beijing, China

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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