A Study of SHR-1701 Plus Platinum-containing Chemotherapy With or Without BP102 (Bevacizumab) as First-line Treatment in Cervical Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-26

Study Completion Date

2024-08-12

Brief Summary

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The study is being conducted to evaluate the efficacy, and safety of SHR-1701 or Placebo Plus Chemotherapy With or Without BP102 (Bevacizumab) as First-Line Treatment in Patients With Persistent, Recurrent, or Metastatic Cervical Cancer.

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Detailed Description

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Conditions

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Cervical Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

SHR-1701 or Placebo Plus Chemotherapy With or Without BP102 (Bevacizumab)

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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SHR-1701 + paclitaxel + cisplatin/carboplatin + BP102

Group Type EXPERIMENTAL

SHR-1701 + paclitaxel + cisplatin/carboplatin + BP102

Intervention Type DRUG

SHR-1701 + paclitaxel + cisplatin/carboplatin + BP102

SHR-1701 + paclitaxel + cisplatin/carboplatin ± BP102

Group Type EXPERIMENTAL

SHR-1701 + paclitaxel + cisplatin/carboplatin± BP102

Intervention Type DRUG

SHR-1701 + paclitaxel + cisplatin/carboplatin± BP102

Placebo + paclitaxel + cisplatin/carboplatin ± BP102

Group Type PLACEBO_COMPARATOR

Placebo + paclitaxel + cisplatin/carboplatin ± BP102

Intervention Type DRUG

Placebo + paclitaxel + cisplatin/carboplatin ± BP102

Interventions

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SHR-1701 + paclitaxel + cisplatin/carboplatin + BP102

Intervention Type DRUG

SHR-1701 + paclitaxel + cisplatin/carboplatin± BP102

Intervention Type DRUG

Placebo + paclitaxel + cisplatin/carboplatin ± BP102

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Aged 18-70 years, female.
2. With Eastern Cooperative Oncology Group (ECOG) performance status scores of 0-1.
3. With a life expectancy of ≥ 12 weeks.
4. Acute toxicities from prior anti-tumor treatments must have resolved to Grade 0-1 (per NCI CTCAE 5.0).
5. With at least one measurable lesion as per RECIST v1.1.
6. With histologically confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma of the cervix.
7. Persistent, recurrent, or metastatic cervical cancer.
8. Patients to be enrolled in Stage II are required to provide a minimum of 10 slides of fresh (preferred).
9. Women of childbearing potential must have a negative serum pregnancy test within 3 days prior to starting study treatment.
10. Patients must agree and have signed the informed consent form.

Exclusion Criteria

1. With known contraindications to paclitaxel, cisplatin, or carboplatin.
2. With known allergies to any of the study drugs or their excipients; severe allergic reactions to other monoclonal antibodies.
3. With inadequately treated CNS metastasis.
4. With uncontrolled hypertension.
5. With uncontrolled cardiac diseases or symptoms.
6. With major vascular disease.
7. With arterial/venous thrombotic events within 6 months prior to randomization.
8. Have received full-dose anticoagulant or hemolytic therapy within 10 days prior to randomization.
9. With clinically significant hemorrhage or definitive bleeding diathesis within 3 months prior to randomization.
10. With severe, unhealed, or open wounds as well as active ulcers or untreated fractures.
11. With any active autoimmune disease or a history of autoimmune disease that is expected to recur.
12. Had other active malignant tumors within 5 years prior to study enrolment.
13. With congenital or acquired immunodeficiency (such as HIV-infected patients).

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No