To Explore the Efficacy and Safety of Camrelizumab Combined With SHR1020 in the Treatment of Advanced Melanoma

November 14, 2022 updated by: Jun Guo, Peking University Cancer Hospital & Institute

A Prospective, Single-center Clinical Study to Explore the Efficacy and Safety of Camrelizumab Combined With SHR1020 in the Treatment of Advanced Melanoma

This study is being conducted to explore the efficacy and safety of camrelizumab combined with SHR1020 in the treatment of advanced melanoma.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This trial is a prospective, single-center, single-arm clinical research. Based on current experience, single agent immunotherapy has limited efficacy in advanced melanoma. SHR1020 is a multi-target tyrosine kinase inhibitor. This study is aiming to evaluate the efficacy and safety of camrelizumab combined with SHR1020 in patients with advanced melanoma. The safety and efficacy of this study will be assessed through ORR, DCR, PFS, OS and adverse effects as graded by CTCAE 5.0.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jun Guo, MD

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100142
        • Recruiting
        • Beijing Cancer Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Has unresectable Stage III or Stage IV melanoma per American Joint Committee on Cancer (AJCC) staging system version 8. At least one measurable lesion conforming to RECIST 1.1 criteria.
  • The toxicity of prior treatment has recovered to ≤1 grade according to CTCAE 5.0 (excepted alopecia).
  • ECOG score 0-1.
  • The expected survival time is ≥ 12 weeks.
  • Had normal swallowing function, without dysfunction of gastrointestinal absorption.
  • Adequate organ and bone marrow function.
  • Female patients of childbearing age must undergo a serum pregnancy test within 7 days before the commencement of the study and the results are negative, and are willing to use a medically approved high potency contraceptive method during the study period and within 12 months after the last administration of the study drug; For male patients whose partner is a female of childbearing age, they should be surgically sterilized or agree to use an effective method of contraception during the study period and for 12 months after administration of the last study.
  • Willing to consent and signed the informed consent, and able comply with the planned visit, research treatment, laboratory examination and other test procedures.

Exclusion Criteria:

  • Other malignant tumors occurred in the past 5 years, except for cured skin basal cell carcinoma, squamous cell carcinoma of skin, early stage prostate cancer and cervical carcinoma in situ.
  • Has uveal melanoma.
  • The patient has previously received anti-angiogenic drugs.
  • The first study drug treatment was less than 4 weeks from the last chemotherapy or 5 half-lives from the last targeted therapy; less than 4 weeks from major surgery; less than7 days from immunosuppressive drug; less than 3 weeks from immunomodulatory; less than 4 weeks from live attenuated vaccine.
  • Systemic antibiotic use for 7 days within 4 weeks prior to initial administration, or unexplained fever during screening/prior to initial administration.
  • Received hematopoietic stimulating factors (eg: G-CSF, EPO) within 1 week prior to initial administration.
  • Patients with central nervous system disease or brain metastases; patients who have received treatment, such as imaging confirmed stable has been maintained for at least 4 weeks, and have stopped systemic hormone therapy for more than 2 weeks, no clinical symptoms can be included.
  • With active autoimmune disease or a history of autoimmune disease.
  • With history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
  • With immunodeficiency, eg HIV, HBV, HCV.
  • Known to be allergic to the active ingredients or excipients in this study.
  • Have a clear history of serious and uncontrolled other disease or mental disorders.
  • Has a bleeding tendency or abnormal clotting function (INR>2.0, PT>16s).
  • Other situations that the researcher considers inappropriate to participate in the research.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Camrelizumab Combined With SHR1020
Camrelizumab combined with SHR1020 for advanced melanoma.
Drug: camrelizumab
camrelizumab combined with SHR1020 for advanced melanoma
Other Names:
  • SHR1210
Drug: SHR1020
camrelizumab combined with SHR1020 for advanced melanoma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR (Objective Response Rate)
Time Frame: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Containing the incidence of complete response (CR) and partial response (PR). Evaluated according to RECIST 1.1 criteria, patients received their first tumor imaging evaluation at 6 weeks after the treatment start, followed by imaging evaluation every 2 cycles.
From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS (Progression-Free-Survival)
Time Frame: From date of treatment start until the date of progression or the date of death due to any caus, assessed up to 12 months
From date of treatment start until the date of progression or the date of death due to any cause. Evaluated according to RECIST 1.1 criteria, patients received their first tumor imaging evaluation at 6 weeks after the treatment start, followed by imaging evaluation every 2 cycles.
From date of treatment start until the date of progression or the date of death due to any caus, assessed up to 12 months
DCR (Disease Control Rate)
Time Frame: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Containing the incidence of complete response (CR), partial response (PR) and stable disease (SD).Evaluated according to RECIST 1.1 criteria, patients received their first tumor imaging evaluation at 6 weeks after the treatment start, followed by imaging evaluation every 2 cycles.
From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
OS (overall survival)
Time Frame: From date of treatment start until the date of death from any cause or censored at the last day that the patient is documented to be alive, whichever came first, assessed up to 24 months
From date of treatment start to any cause death or last follow-up.
From date of treatment start until the date of death from any cause or censored at the last day that the patient is documented to be alive, whichever came first, assessed up to 24 months
6mPFS
Time Frame: Up to 6 months
6-month- Progression-Free-Survival rate. Evaluated according to RECIST 1.1 criteria, patients received their first tumor imaging evaluation at 6 weeks after the treatment start, followed by imaging evaluation every 2 cycles.
Up to 6 months
Adverse events (per CTCAE v5.0 criteria)
Time Frame: Up to 12months
To evaluate the adverse events of patients with advanced melanoma after treated with camrelizumab plus SHR1020.
Up to 12months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Cancer Hospital & Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 9, 2021

Primary Completion (Anticipated)

August 30, 2024

Study Completion (Anticipated)

August 30, 2024

Study Registration Dates

First Submitted

September 15, 2021

First Submitted That Met QC Criteria

September 15, 2021

First Posted (Actual)

September 21, 2021

Study Record Updates

Last Update Posted (Actual)

November 17, 2022

Last Update Submitted That Met QC Criteria

November 14, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MM-IIT-SHR1210-FMTN

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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