A Study of SHR-1210± SHR-1020 Versus Chemotherapy in Patients With Recurrent or Metastatic Cervical Cancer

  • STATUS
    Recruiting
  • End date
    Jun 30, 2023
  • participants needed
    153
  • sponsor
    Jiangsu HengRui Medicine Co., Ltd.
Updated on 22 March 2022

Summary

This is a randomized, open-label, 3-arm Phase 2 study to evaluate the efficacy and safety of SHR-1210 alone or with SHR-1020 versus physician's choice chemotherapy in recurrent or metastatic cervical cancer patients. All enrolled patients will be randomly divided into 3 groups and receive treatment until disease progression, intolerable toxicity,any criterion for stopping the study drug or SHR-1210 treatment for up to 2 years.

Description

This is a randomized, open-label, 3-arm Phase 2 study to evaluate the efficacy and safety of SHR-1210 alone or with SHR-1020 versus physician's choice chemotherapy in recurrent or metastatic cervical cancer patients. All enrolled patients will be randomly divided into 3 groups and receive treatment until disease progression, intolerable toxicity,any criterion for stopping the study drug or SHR-1210 treatment for up to 2 years.The primary study hypotheses are that the combination of SHR-1210 plus SHR-1020 is superior to SHR-1210 or physician's choice chemotherapy with respect to: 1) Progression free survival(PFS) in recurrent or metastatic cervical cancer patients(SHR-1210+SHR-1020 versus SHR-1210;2) Overall survival(OS) in recurrent or metastatic cervical cancer patients(SHR-1210+SHR-1020 versus Physician's choice chemotherapy).

Details
Condition Recurrent or Metastatic Cervical Cancer
Treatment SHR-1210, Physician's choice chemotherapy, SHR-1020
Clinical Study IdentifierNCT04680988
SponsorJiangsu HengRui Medicine Co., Ltd.
Last Modified on22 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Voluntarily agree to participate by giving written informed consent
Histologically or cytologically confirmed diagnosis of squamous-cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix
The patients relapsed after a platinum-based treatment regimen for recurrent or metastatic disease
Patients must provide a fresh biopsy. If not, sufficient and adequate tumor tissue sample from the most recent biopsy of a tumor lesion will be required for PD-L1 expression
Has measurable lesion on imaging based on RECIST version 1.1
Have a life expectancy of at least 3 months
ECOG performance status 0-1
If childbearing potential, female patients must be willing to use at least 1 adequate barrier methods throughout the study, starting with the screening visit through 6 months after the last dose of study treatment

Exclusion Criteria

Has any malignancy <5 years prior to study entry. Except for curative skin basal cell carcinoma, carcinoma in situ or breast cancer >3 years
Has received prior therapy with: anti-PD-1, anti-PD-L1, or anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4) antibodies; Famitinib; patient is allergic to monoclonal antibody
Known to have autoimmune disease
Recived other anticancer therapy 4 weeks before randomization
Known to be human immunodeficiency virus positive, active hepatitis B virus, or active hepatitis C virus
Untreated and/or uncontrolled brain metastases
With high risk of vaginal bleeding or gastrointestinal perforation
Clear my responses

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