Clinical trial NCT04680988: A Study of SHR-1210± SHR-1020 Versus Chemotherapy in Patients With Recurrent or Metastatic Cervical Cancer
Official title: A Randomized,Open-label, Multi-Center, Phase II Clinical Trial to Assess the Efficacy and Safety of SHR-1210± SHR-1020 Versus Physician's Choice Chemotherapy in the Treatment of Recurrent or Metastatic Cervical Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Recurrent or Metastatic Cervical Cancer
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-12-23
Enrollment: 194
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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).

Eligibility criteria: Inclusion Criteria:

1. Voluntarily agree to participate by giving written informed consent.
2. Histologically or cytologically confirmed diagnosis of squamous-cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix.
3. The patients relapsed after a platinum-based treatment regimen for recurrent or metastatic disease.
4. 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.
5. Has measurable lesion on imaging based on RECIST version 1.1.
6. Have a life expectancy of at least 3 months.
7. ECOG performance status 0-1.
8. 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:

1. Has any malignancy \<5 years prior to study entry. Except for curative skin basal cell carcinoma, carcinoma in situ or breast cancer \>3 years.
2. 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.
3. Known to have autoimmune disease.
4. Recived other anticancer therapy 4 weeks before randomization.
5. Known to be human immunodeficiency virus positive, active hepatitis B virus, or active hepatitis C virus.
6. Untreated and/or uncontrolled brain metastases.
7. With high risk of vaginal bleeding or gastrointestinal perforation.

Primary outcomes:
measure: Objective Response Rate (ORR) assessed by Blinded Independent Central Review in recurrent or metastatic cervical cancer patients(SHR-1210+Famitinib versus SHR-1210)
timeFrame: Up to approximately 2 years
Secondary outcomes:
measure: Progression free survival (PFS) in recurrent or metastatic cervical cancer patients(SHR-1210+Famitinib versus SHR-1210)
timeFrame: Up to approximately 2 years
measure: Overall survival (OS) in recurrent or metastatic cervical cancer patients(SHR-1210+Famitinib versus SHR-1210)
timeFrame: Up to approximately 2 years
measure: Objective Response Rate (ORR) assessed by investigator in recurrent or metastatic cervical cancer patients(SHR-1210+Famitinib versus SHR-1210)
timeFrame: Up to approximately 2 years
measure: Disease control rate (DCR)，recurrent or metastatic cervical cancer patients(SHR-1210+Famitinib versus SHR-1210) according to RECIST 1.1 criteria
timeFrame: Up to approximately 2 years
measure: Duration of response (DoR), in recurrent or metastatic cervical cancer patients(SHR-1210+Famitinib versus SHR-1210) according to RECIST 1.1 criteria.
timeFrame: Up to approximately 2 years
measure: Time to response (TTR), in recurrent or metastatic cervical cancer patients(SHR-1210+Famitinib versus SHR-1210) according to RECIST 1.1 criteria.
timeFrame: Up to approximately 2 years
measure: Time to treatment failure (TTF)，in recurrent or metastatic cervical cancer patients(SHR-1210+Famitinib versus SHR-1210) according to RECIST 1.1 criteria.
timeFrame: Up to approximately 2 years
measure: Adverse Events (AEs)
timeFrame: from the first drug administration to within 90 days for the last treatment dose
measure: Tolerance
timeFrame: from the first drug administration to within 90 days for the last treatment dose
measure: Characteristic of Anti drug antibody
timeFrame: from the first drug administration to within 90 days for the last treatment dose
measure: Peak Serum Concentration of SHR-1210
timeFrame: from the first drug administration to within 90 days for the last treatment dose
measure: Peak Plasma Concentration of famitinib
timeFrame: from the first drug administration to within 90 days for the last treatment dose
measure: Area under the Serum Concentration versus Time Curve of SHR-1210
timeFrame: from the first drug administration to within 90 days for the last treatment dose
measure: Area under the Plasma Concentration versus Time Curve of famitinib
timeFrame: from the first drug administration to within 90 days for the last treatment dose
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
References: