Phase II Bintrafusp alfa Monotherapy in Platinum-Experienced Cervical Cancer
- Conditions
- cervical cancer
- Registration Number
- JPRN-jRCT2080225117
- Lead Sponsor
- Merck Biopharma Co., Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- Female
- Target Recruitment
- 135
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 metastatic disease or in the adjuvant or neo-adjuvant setting.
2. Participants who were intolerant to or ineligible for platinum-based chemotherapy are also eligible.
3. Participants must be naive 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 and be on a stable dose of antiviral therapy.
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
-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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>1. 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 ]
- Secondary Outcome Measures
Name Time Method