bintrafusp alfa combination therapy in participants with cervical cancer (intr@pid 046)

Conditions: Cervical Cancer

Summary: 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.


Eligibility criteria:
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

Keywords: advanced cervical cancer bintrafusp alfa m7824 intr@pid transforming growth factor-beta programmed death-ligand 1