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

NCT05179239TerminatedPHASE3INTERVENTIONAL

Summary

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.

Key Facts

Lead Sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Enrollment

Start Date

2022-02-26

Completion Date

2024-08-12

Study Type

INTERVENTIONAL

Official Title

A Randomized，Double-blind，Controlled，Multi-center Phase III Clinical Study Evaluating SHR-1701 or Placebo Plus Chemotherapy With or Without BP102 (Bevacizumab) as First-Line Treatment in Patients With Persistent, Recurrent, or Metastatic Cervical Cancer

Interventions

SHR-1701 + paclitaxel + cisplatin/carboplatin + BP102SHR-1701 + paclitaxel + cisplatin/carboplatin± BP102Placebo + paclitaxel + cisplatin/carboplatin ± BP102

Conditions

Cervical Cancer

Eligibility

Age Range

18 Years – 70 Years

Sex

FEMALE

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).

Outcome Measures

Primary Outcomes

Incidence and severity of Participants Who Experience an Adverse Event (AE) as per NCI-CTC AE 5.0（Stage I）

Time frame: Up to approximately 21 days

Incidence and severity of Participants Who Experience a Serious AE (SAE) as per NCI-CTC AE 5.0（Stage I）

Time frame: Up to approximately 21 days

Incidence and severity of Participants Who Experience an Immune-related AE (irAE) as per NCI-CTC AE 5.0（Stage I）

Time frame: Up to approximately 21 days

BIRC-assessed progression-free survival (PFS) as per RECIST v1.1（Stage II）

Time frame: Up to approximately 10 months

OS is defined as the time from randomization to death due to any cause. （Stage II）

Time frame: Up to approximately 26 months

Secondary Outcomes

Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by Investigator （Stage I）

Time frame: Up to approximately 26 months

Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Investigator （Stage I）

Time frame: Up to approximately 26 months

Disease Control Rate (DCR)up to approximately 26 months（Stage I）

Time frame: up to approximately 26 months

Duration of Response (DOR) Per RECIST 1.1 as Assessed by Investigator （Stage I）

Time frame: Up to approximately 26 months

Time to Progress(TTP) up to approximately 26 months（Stage I）

The time from the date of the first medication to the date of the first recording of tumor progression (as measured according to THE RECIST v1.1 criteria, regardless of whether treatment is continued or not).

Time frame: up to approximately 26 months

Overall survival (OS) up to approximately 26 months（Stage I）

Time frame: up to approximately 26 months

Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by BIRC- and investigator（Stage II）

Time frame: Up to approximately 26 months

Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by BIRC- and investigator（Stage II）

Time frame: Up to approximately 26 months

Disease Control Rate (DCR)Per RECIST 1.1 as Assessed by BIRC- and investigator（Stage II）

Time frame: Up to approximately 26 months

Duration of Response (DOR) Per RECIST 1.1 as Assessed by BIRC- and investigator （Stage II）

Time frame: Up to approximately 26 months

Time to Progress(TTP) up to approximately 26 months （Stage II）

The time from the date of randomization to the date of the first recording of tumor progression (as measured according to THE RECIST v1.1 criteria, regardless of whether treatment is continued or not).

Time frame: up to approximately 26 months

Incidence and severity of Participants Who Experience an Adverse Event (AE) as per NCI-CTC AE 5.0 （Stage II）

Time frame: Up to approximately 26 months

Incidence and severity of Participants Who Experience a Serious AE (SAE) as per NCI-CTC AE 5.0（Stage II）

Time frame: Up to approximately 26 months

Incidence and severity of Participants Who Experience an Immune-related AE (irAE) as per NCI-CTC AE 5.0（Stage II）

Time frame: Up to approximately 26 months.

Locations

Sun Yat-sen University Cancer Center, Guangzhou, China

Linked Papers

SHR-1701, a Bifunctional Fusion Protein Targeting PD-L1 and TGFβ, for Recurrent or Metastatic Cervical Cancer: A Clinical Expansion Cohort of a Phase I Study

Abstract Purpose: Patients with recurrent or metastatic cervical cancer have limited treatment options after platinum-containing treatment. We initiated a phase I study to assess SHR-1701, a novel bifunctional fusion protein composed of a mAb against programmed death ligand 1 (PD-L1) fused with the extracellular domain of TGFβ receptor II, in solid tumors (NCT03774979). Here, results from the cervical cancer cohort are presented. Patients and Methods: Patients with recurrent or metastatic cervical cancer who progressed during or after platinum-based therapy were enrolled to receive SHR-1701 at 30 mg/kg every 3 weeks. Primary endpoint was objective response rate (ORR) per RECIST v1.1. Results: In total, 32 patients were recruited. ORR was 15.6% [95% confidence interval (CI), 5.3–32.8], and disease control rate was 50.0% (95% CI, 31.9–68.1). Responses were still ongoing in 80.0% of the responders; 6-month duration of response rate was 80.0% (95% CI, 20.4–96.9). Median progression-free survival (PFS) was 2.7 months (95% CI, 1.4–4.1). Of note, as assessed by immune-modified RECIST, median PFS was 4.1 months (95% CI, 1.6–4.3). Overall survival rate at 12 months was 54.6% (95% CI, 31.8–72.7). Treatment-related adverse events of grade 3 or 4 were reported in 11 (34.4%) patients. No treatment-related deaths occurred. No difference in ORR was found between patients with PD-L1 combined positive score ≥1 or &lt;1; patients with high phosphorylated SMAD2 level in immune cells or tumor cells had numerically higher ORR. Conclusions: SHR-1701 exhibits encouraging antitumor activity and controllable safety in patients with recurrent or metastatic cervical cancer after platinum-based regimens, and therefore might provide another treatment option for this population. See related commentary by Miller and Friedman, p. 5238

Linked Investigators

Jifeng Feng