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

Suzhou Suncadia Biopharmaceuticals

Status and phase: Terminated; Phase 3

Conditions: Cervical Cancer

Treatments: Drug: SHR-1701 + paclitaxel + cisplatin/carboplatin + BP102; Drug: Placebo + paclitaxel + cisplatin/carboplatin ± BP102; Drug: SHR-1701 + paclitaxel + cisplatin/carboplatin± BP102

Study type: Interventional

Funder types: Industry

Identifiers

NCT05179239

SHR-1701-III-309

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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31 participants in 3 patient groups, including a placebo group

SHR-1701 + paclitaxel + cisplatin/carboplatin + BP102

Experimental group

Treatment:

Drug: SHR-1701 + paclitaxel + cisplatin/carboplatin + BP102

SHR-1701 + paclitaxel + cisplatin/carboplatin ± BP102

Experimental group

Treatment:

Drug: SHR-1701 + paclitaxel + cisplatin/carboplatin± BP102

Placebo + paclitaxel + cisplatin/carboplatin ± BP102

Placebo Comparator group

Treatment:

Drug: Placebo + paclitaxel + cisplatin/carboplatin ± BP102