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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