# Gemcitabine Plus Cisplatin With or Without Bintrafusp Alfa (M7824) in Participants With 1L BTC

> **NCT04066491** · PHASE2,PHASE3 · TERMINATED · sponsor: **EMD Serono Research & Development Institute, Inc.** · enrollment: 309 (actual)

## Conditions studied

- Biliary Tract Cancer
- Cholangiocarcinoma
- Gallbladder Cancer

## Interventions

- **DRUG:** M7824
- **DRUG:** Placebo
- **DRUG:** Gemcitabine
- **DRUG:** Cisplatin

## Key facts

- **NCT ID:** NCT04066491
- **Lead sponsor:** EMD Serono Research & Development Institute, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE2,PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2019-09-20
- **Primary completion:** 2021-05-20
- **Final completion:** 2022-11-10
- **Target enrollment:** 309 (ACTUAL)
- **Why stopped:** Based on a review of data conducted by the Independent Data Monitoring Committee (IDMC), Sponsor decided to discontinue this study as the study was unlikely to achieve the primary objective of overall survival.
- **Last updated:** 2023-11-14

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04066491

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04066491, "Gemcitabine Plus Cisplatin With or Without Bintrafusp Alfa (M7824) in Participants With 1L BTC". Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/clinical/NCT04066491. Licensed CC0.

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