Description:
The main purpose of this study is to evaluate clinical efficacy and safety of bintrafusp alfa
in participants with advanced, unresectable cervical cancer with disease progression during
or after platinum-containing chemotherapy.
Title
- Brief Title: Bintrafusp Alfa Monotherapy in Platinum-Experienced Cervical Cancer
- Official Title: A Phase II, Multicenter, Open Label Study of Bintrafusp Alfa (M7824) Monotherapy in Participants With Advanced, Unresectable Cervical Cancer With Disease Progression During or After Platinum-Containing Chemotherapy
Clinical Trial IDs
- ORG STUDY ID:
MS200647_0017
- SECONDARY ID:
2019-003583-40
- NCT ID:
NCT04246489
Conditions
- Uterine Cervical Neoplasms
Interventions
Drug | Synonyms | Arms |
---|
Bintrafusp alfa | M7824 | Bintrafusp alfa |
Purpose
The main purpose of this study is to evaluate clinical efficacy and safety of bintrafusp alfa
in participants with advanced, unresectable cervical cancer with disease progression during
or after platinum-containing chemotherapy.
Trial Arms
Name | Type | Description | Interventions |
---|
Bintrafusp alfa | Experimental | | |
Eligibility Criteria
Inclusion Criteria:
- Participants have advanced unresectable and/or metastatic cervical cancer (squamous
cell carcinoma, adenocarcinoma, adenosquamous cell carcinoma) with disease progression
during or after the prior platinum-containing chemotherapy:
1. The prior platinum-containing chemotherapy may be a systemic treatment for
advanced unresectable, recurrent, persistent or metastatic disease or treatment
in the adjuvant or neo-adjuvant setting with disease progression or recurrence
within 6 months of completion of platinum-containing chemotherapy
2. Participants who previously only received platinum as a radiosensitizer are not
eligible
3. Participants must be naïve to checkpoint inhibitors
- Participants must have measurable disease
- Participants must provide a tumor tissue sample, either from archival tissue or newly
obtained core or excisional biopsy. If the participant received local therapy (For
example: radiation therapy or chemoradiotherapy) after the archival tissue was taken,
a new biopsy will be required
- Participants who have Eastern Cooperative Oncology Group (ECOG) PS of 0 to 1
- Life expectancy greater than or equals to (>=) 12 weeks as judged by the Investigator
- Adequate hematological, hepatic and renal function as defined in the protocol
- Participants with known Human Immunodeficiency Virus (HIV) infections are in general
eligible if the following criteria are met:
1. Clinically indicated participants must be stable on antiretroviral therapy (ART)
for at least 4 weeks and agree to adhere to ART
2. have no evidence of documented multi-drug resistance that would prevent effective
ART
3. Have an HIV viral load of < 400 copies per milliliter (/mL) at Screening
4. Have CD4+ T-cell (CD4+) counts >= 350 cells/microliter
5. For participants with a history of an Acquired immunodeficiency syndrome
(AIDS)-defining opportunistic infection within the last 12 months, participants
may be eligible only after consultation and agreement with the study Medical
Monitor
6. If prophylactic antimicrobial drugs are indicated, participants may still be
considered eligible upon agreement with the study Medical Monitor
- Participants with hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infections
are in general eligible if the following criteria are met:
1. HBV viral load below the limit of quantification. If medically indicated,
participants infected with HBV must be treated and on a stable dose of antivirals
at study entry and with planned monitoring and management according to
appropriate labeling guidance
2. Participants with a history of HCV infection should have completed curative
antiviral treatment and require HCV viral load below the limit of quantification
3. Participants on concurrent HCV treatment should have HCV below the limit of
quantification
- Other protocol defined inclusion criteria could apply
Exclusion Criteria:
- Participants with active central nervous system (CNS) metastases causing clinical
symptoms or require therapeutic intervention are excluded. Participants with a history
of treated CNS metastases (by surgery or radiation therapy) are not eligible unless
they have fully recovered from treatment, demonstrated no progression for at least 4
weeks, and are not using steroids for at least 7 days prior to the start of study
treatment
- Participants with interstitial lung disease or has had a history of pneumonitis that
has required oral or intravenous (IV) steroids
- Participants with significant acute or chronic infections
- Participants with active autoimmune disease that might deteriorate when receiving an
immunostimulatory agent
- Participants with clinically significant cardiovascular/cerebrovascular disease
including: cerebral vascular accident/stroke, myocardial infarction, unstable angina,
congestive heart failure, or serious cardiac arrhythmia
- Other protocol defined exclusion criteria could apply
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | Female |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Confirmed Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) as Evaluated by Independent Review Committee |
Time Frame: | Time from first treatment to planned final assessment at approximately 2 years |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Independent Review Committee (IRC) |
Time Frame: | Time from first treatment to planned final assessment at approximately 2 years |
Safety Issue: | |
Description: | |
Measure: | Durable Response of at Least 6 Months According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Independent Review Committee (IRC) |
Time Frame: | Time from first treatment to planned final assessment at approximately 2 years |
Safety Issue: | |
Description: | |
Measure: | Occurrence of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related AEs, Including Adverse Events of Special Interest (AESIs) |
Time Frame: | Time from first treatment to planned final assessment at approximately 2 years |
Safety Issue: | |
Description: | |
Measure: | Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Independent Review Committee (IRC) |
Time Frame: | Time from first treatment to planned final assessment at approximately 2 years |
Safety Issue: | |
Description: | |
Measure: | Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator |
Time Frame: | Time from first treatment to planned final assessment at approximately 2 years |
Safety Issue: | |
Description: | |
Measure: | Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator |
Time Frame: | Time from first treatment to planned final assessment at approximately 2 years |
Safety Issue: | |
Description: | |
Measure: | Durable Response According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator |
Time Frame: | Time from first treatment to planned final assessment at approximately 2 years |
Safety Issue: | |
Description: | |
Measure: | Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator |
Time Frame: | Time from first treatment to planned final assessment at approximately 2 years |
Safety Issue: | |
Description: | |
Measure: | Overall Survival (OS) |
Time Frame: | Time from first treatment to planned final assessment at approximately 2 years |
Safety Issue: | |
Description: | |
Measure: | Concentration of bintrafusp alfa at the end of Infusion (Ceoi) |
Time Frame: | Time from first treatment to planned final assessment at approximately 2 years |
Safety Issue: | |
Description: | |
Measure: | Concentration of bintrfusp alfa at the end of the Dosing Interval (C trough) |
Time Frame: | Time from first treatment to planned final assessment at approximately 2 years |
Safety Issue: | |
Description: | |
Measure: | Immunogenicity as measured by Anti-drug Antibodies Concentration |
Time Frame: | Time from first treatment to planned final assessment at approximately 2 years |
Safety Issue: | |
Description: | |
Measure: | Confirmed Objective Response According to RECIST Version 1.1 Assessed by Independent Review Committee (IRC) According to Programmed Death Ligand 1 (PD-L1) Expression |
Time Frame: | Time from first treatment to planned final assessment at approximately 2 years |
Safety Issue: | |
Description: | |
Measure: | Duration of Response (DOR) According to (RECIST Version 1.1) Assessed by an Independent Review Committee (IRC) According to Programmed Death Ligand 1 (PD-L1) Expression |
Time Frame: | Time from first treatment to planned final assessment at approximately 2 years |
Safety Issue: | |
Description: | |
Measure: | Durable Response According to RECIST Version 1.1 Assessed by an Independent Review Committee (IRC) According to Programmed Death Ligand 1 (PD-L1) Expression |
Time Frame: | Time from first treatment to planned final assessment at approximately 2 years |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | EMD Serono Research & Development Institute, Inc. |
Trial Keywords
- M7824
- INTR@PID
- Bintrafusp alfa
- programmed death-ligand 1
- Cervical Cancer
- Transforming growth factor-β (TGF-β)
Last Updated
February 16, 2021