CompletedPhase 1

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

United States, Japan, Spain25 participantsStarted 2020-10-19

Plain-language 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 * Oth…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With Dose-Limiting Toxicities (DLTs)

Timeframe: Up to 4 weeks after first administration of study intervention

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Timeframe: Time from first treatment assessed up to approximately 20 months

Trial details

NCT IDNCT04551950

SponsorEMD Serono Research & Development Institute, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-06-15

Results submitted2023-07-31

View on ClinicalTrials.gov More Cervical Cancer trials