Clinical trial · Interventional
Bintrafusp Alfa Combination Therapy in Participants With Cervical Cancer (INTR@PID 046)
Safety Study of Bintrafusp Alfa in Combination With Other Anti-cancer Therapies in Participants With Locally Advanced or Advanced Cervical Cancer (INTR@PID 046)
NCT04551950CI-TRIAL-00074835completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Carboplatin | Drug | Carboplatin | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| M7824 | Drug | — | UNRESOLVED |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Cohort 1A:M7824+Cisplatin/Carboplatin+Paclitaxel+Bevacizumab
- interventionNames
- Drug: M7824
- Drug: Carboplatin
- Drug: Paclitaxel
- Drug: Bevacizumab
- Drug: Cisplatin
- type
- EXPERIMENTAL
- label
- Cohort1B:M7824+Cisplatin or Carboplatin+Paclitaxel
- interventionNames
- Drug: M7824
- Drug: Carboplatin
- Drug: Paclitaxel
- Drug: Cisplatin
- type
- EXPERIMENTAL
- label
- Cohort 2: M7824+Cisplatin+ Radiotherapy
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.