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

Not Recruiting

Trial ID: NCT04551950

Purpose

This study was 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.

Official Title

Safety Study of Bintrafusp Alfa in Combination With Other Anti-cancer Therapies in Participants With Locally Advanced or Advanced Cervical Cancer (INTR@PID 046)

Eligibility


Inclusion Criteria:

   - Inclusion Criteria for participants enrolling into Cohort 1:

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

   - Study participants had not been treated with systemic chemotherapy and were not
   amenable to curative treatment

   - Prior radiation with or without radio-sensitizing chemotherapy was allowed

   - Inclusion Criteria for participants enrolling into Cohort 2:

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

   - Participants had 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 was required

   - Participants who had Eastern Cooperative Oncology Group (ECOG) Performance status (PS)
   of 0 to 1 were eligible

   - Participants had a life expectancy greater than or equal to 12 weeks

   - Participants had adequate hematological, hepatic, renal, and coagulation function as
   defined in the protocol

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

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

   - Other protocol defined inclusion criteria could apply

Exclusion Criteria:

   - Exclusion Criteria for All Participants were:

   - Participants with active central nervous system (CNS) metastases causing clinical
   symptoms or metastases that required therapeutic intervention were excluded.
   Participants with a history of treated CNS metastases (by surgery or radiation
   therapy) were not eligible unless they had fully recovered from treatment,
   demonstrated no progression for at least 4 weeks, and were 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 did not require
   immuno-suppression

   - Participants with significant acute or chronic infections

   - Participants with active autoimmune disease that might have deteriorated when
   receiving an immuno-stimulatory agent

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

   - Participants with a history of bleeding diathesis or recent major bleeding events

   - Participant that had 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 were:

   - 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 a 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

Intervention(s):

drug: M7824

drug: Carboplatin

drug: Paclitaxel

drug: Bevacizumab

drug: Cisplatin

radiation: Radiotherapy

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Akschy Peer
650-736-0792

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