Bintrafusp Alfa Combination Therapy in Participants With Cervical Cancer (INTR@PID 046)

• Status: Active, not recruiting
• Trial end date: 2024-05-24
• Target enrollment: 0
• Participant gender: Female

Summary

This study is to evaluate the safety and tolerability of bintrafusp alfa in combination with other anti-cancer therapies in participants with locally advanced or advanced cervical cancer.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: EMD Serono Research & Development Institute, Inc.
• Collaborator: Merck KGaA, Darmstadt, Germany
• Treatments: Bevacizumab; Carboplatin; Paclitaxel

Criteria

Inclusion Criteria:

• Inclusion Criteria for participants enrolling into Cohort 1:

• Study participants have documented persistent, recurrent, or metastatic squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix

• Study participants have not been treated with systemic chemotherapy and are not amenable to curative treatment

• Prior radiation with or without radio-sensitizing chemotherapy is allowed

• Inclusion Criteria for participants enrolling into Cohort 2:

• Participants have documented evidence of cervical adenocarcinoma, squamous cell carcinoma, or adenosquamous carcinoma International Federation of Gynecology and Obstetrics (FIGO) 2018 Stages 1B2 to 4A

• Participants have not received prior chemotherapy or radiotherapy for cervical cancer

• Inclusion Criteria for all participants:

• Archival tumor tissue sample or newly obtained core or excisional biopsy is required

• Participants who have Eastern Cooperative Oncology Group (ECOG) Performance status (PS) of 0 to 1

• Participants have a life expectancy greater than or equal to 12 weeks

• Participants have adequate hematological, hepatic, renal and coagulation function as defined in the protocol

• Participants with known Human immunodeficiency virus (HIV) infections are eligible if the criteria described in the protocol are met

• Participants with Hepatitis B virus (HBV) and/or Hepatitis C virus (HCV) infections are eligible if the criteria described in the protocol are met

• Other protocol defined inclusion criteria could apply

Exclusion Criteria:

• Exclusion Criteria for All Participants:

• Participants with active central nervous system (CNS) metastases causing clinical symptoms or metastases that require therapeutic intervention are excluded.Participants with a history of treated CNS metastases (by surgery or radiation therapy) are not eligible unless they have fully recovered from treatment, demonstrated no progression for at least 4 weeks, and are not using steroids for at least 7 days prior to the start of study intervention

• Participants that received any organ transplantation, including allogeneic stem-cell transplantation, but with the exception of transplants that do not require immuno-suppression

• Participants with significant acute or chronic infections

• Participants with active autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent

• Participants with clinically significant cardiovascular/cerebrovascular disease including: cerebral vascular accident/stroke, myocardial infarction, unstable angina, congestive heart failure, or serious cardiac arrhythmia

• Participants with history of bleeding diathesis or recent major bleeding events

• Participant that has received prior cancer treatment with any other immunotherapy or checkpoint inhibitors or any other immune-modulating monoclonal antibody (mAb)

• Exclusion Criteria for Participants in Cohort 1A related to use of bevacizumab:

• Participants with inadequately controlled hypertension

• Prior history of hypertensive crisis or hypertensive encephalopathy

• Participants with significant vascular disease within 6 months prior to Screening

• Participants with history of hemoptysis within 1 month prior to Screening

• Current use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic purposes

• Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to the first dose of bevacizumab

• Participants with a history of abdominal or trache-oesophageal fistula or gastrointestinal (GI) perforation within 6 months prior to Screening

• Participants with clinical signs of GI obstruction or requirement for routine parenteral hydration, parenteral nutrition, or tube feeding

• Participants with evidence of abdominal free air not explained by paracentesis or recent surgical procedure

• Participants with serious, non-healing wound, active ulcer, or untreated bone fracture

• Participants with proteinuria

• Other protocol defined exclusion criteria could apply