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

NCT05051865 | Unknown Phase 2

• 1 other identifier: MM-IIT-SHR1210-FMTN
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Melanoma

Outcome Measures

Primary Outcomes (1)

• ORR (Objective Response Rate)

  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 Outcomes (5)

• PFS (Progression-Free-Survival)

  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)

  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)

  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

  Up to 6 months

• Adverse events (per CTCAE v5.0 criteria)

  Up to 12months

Study Arms (1)

Camrelizumab Combined With SHR1020

EXPERIMENTAL

Camrelizumab combined with SHR1020 for advanced melanoma.

Drug: camrelizumab; Drug: SHR1020

Interventions

camrelizumab DRUG

camrelizumab combined with SHR1020 for advanced melanoma

Also known as: SHR1210

Camrelizumab Combined With SHR1020

SHR1020 DRUG

camrelizumab combined with SHR1020 for advanced melanoma

Camrelizumab Combined With SHR1020

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Conditions

Melanoma

Interventions

camrelizumab; 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 Officials

• Jun Guo, MD

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lili Mao, MD

CONTACT

13261859885; yunzhongmanbu7848@163.com

Jun Guo, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: September 15, 2021
• First Posted: September 21, 2021
• Study Start: October 9, 2021
• Primary Completion: August 30, 2024
• Study Completion: August 30, 2024
• Last Updated: November 17, 2022

Record last verified: 2022-11

Locations

CN (1)