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

Part of paid clinical trials in Stanford, California.

Sponsor
EMD Serono Research & Development Institute, Inc.
Study ID
NCT04551950
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • M7824 — DRUG
    Participants received bintrafusp alfa until confirmed disease progression, death, unacceptable toxicity and study withdrawal maximum of 2 years (at the discretion of the Investigator).
  • Carboplatin — DRUG
    Carboplatin was administered intravenously as per standard of care.
  • Paclitaxel — DRUG
    Paclitaxel was administered intravenously as per standard of care.
  • Bevacizumab — DRUG
    Bevacizumab was administrated as indicated for standard of care.
  • Cisplatin — DRUG
    Cisplatin was administered intravenously as per standard of care.
  • Radiotherapy — RADIATION
    Participants received radiotherapy as per standard of care.

Study Details

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.

Key Dates

First listed
Sep 16, 2020
Start date
Oct 19, 2020
Status verified
Jul 2023
Primary completion
Jun 15, 2022
Completion
Jun 30, 2022

Study Design

Enrollment
25 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1A:M7824+Cisplatin/Carboplatin+Paclitaxel+Bevacizumab
  • Experimental: Cohort1B:M7824+Cisplatin or Carboplatin+Paclitaxel
  • Experimental: Cohort 2: M7824+Cisplatin+ Radiotherapy

Primary Outcome Measure

Number of Participants With Dose-Limiting Toxicities (DLTs) [ Time Frame: Up to 4 weeks after first administration of study intervention ]

Locations (5)

FacilityCityStateZIPSite coordinators
Stanford Health Care Hospital & ClinicsStanfordCalifornia94305-
Augusta University - formerly Georgia Regents UniversityAugustaGeorgia30912-
Comprehensive Cancer Centers of NevadaHendersonNevada89074-
University of Cincinnati Physicians Group, LLC - Pharmatech Oncology, IncCincinnatiOhio45206-
UT Southwestern Medical CenterDallasTexas75390-

Find similar trials in Stanford, CA

By condition
Cervical cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Stanford Health Care Hospital & Clinics· Stanford, CAAugusta University - formerly Georgia Regents University· Augusta, GAComprehensive Cancer Centers of Nevada· Henderson, NVUniversity of Cincinnati Physicians Group, LLC - Pharmatech Oncology, Inc· Cincinnati, OHUT Southwestern Medical Center· Dallas, TX

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