Clinical Trials List
Protocol NumberWO42017
NCT Number(ClinicalTrials.gov Identfier)NCT04300647
Completed
2020-05-01 - 2025-12-31
Phase II
Recruiting5
ICD-10C53.0
Malignant neoplasm of endocervix
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9180.0
Malignant neoplasm of endocervix
A Phase II, Safety, and Efficacy Study of Tiragolumab Plus Atezolizumab and Atezolizumab Monotherapy in Patients With Metastatic and/or Recurrent PD-L1-Positive Cervical Cancer
-
Trial Applicant
-
Sponsor
Hoffmann-La Roche
-
Trial scale
Multi-Regional Multi-Center
-
Update
2026/02/01
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Ting-Chang Chang Division of Obstetrics & Gynecology
- 黃彥綾 Division of Radiology
- 黃寬仁 Division of Obstetrics & Gynecology
- 周宏學 Division of Obstetrics & Gynecology
- 周宏學 Division of Obstetrics & Gynecology
- Yun-Hsin Tang Division of Obstetrics & Gynecology
- Chyong-Huey Lai Division of Obstetrics & Gynecology
- Angel Chao Division of Obstetrics & Gynecology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Huann-Cheng Horng Division of Obstetrics & Gynecology
- 吳華席 Division of Obstetrics & Gynecology
- Chi-Mu Chuang Division of Obstetrics & Gynecology
- Yi-Jen Chen Division of Obstetrics & Gynecology
- 沈書慧 Division of Radiology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 戴依柔 Division of Obstetrics & Gynecology
- 陳祈安 Division of Obstetrics & Gynecology
- YING-CHENG CHIANG Division of Obstetrics & Gynecology
- 童寶玲 Division of Obstetrics & Gynecology
- 施怡倫 Division of Radiology
- BOR-CHING SHEU Division of Obstetrics & Gynecology
- CHI-HAU CHEN CHI-HAU CHEN Division of Obstetrics & Gynecology
- 郭冠廷 Division of Others
- 陳宇立 Division of Obstetrics & Gynecology
- - - Division of Obstetrics & Gynecology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Metastatic and/or Recurrent PD-L1-Positive Cervical Cancer
Objectives
The purpose of this study is to evaluate the efficacy and safety of tiragolumab in combination with atezolizumab and atezolizumab monotherapy in patients with programmed death-ligand 1 (PD-L1)-positive cervical cancer (metastatic and/or recurrent).
Test Drug
Tiragolumab/TECENTRIQ (Atezolizumab)
Active Ingredient
Atezolizumab
Tiragolumab
Tiragolumab
Dosage Form
IVT
IVT
IVT
Dosage
1200mg/20ml
600mg/10ml
600mg/10ml
Endpoints
Primary Outcome Measures :
Independent Review Committee (IRC)-Assessed Objective Response Rate (ORR) [ Time Frame: From randomization up to 36 months ]
Secondary Outcome Measures :
Percentage of Participants With Adverse Events [ Time Frame: Up to 36 months ]
IRC-Assessed Duration of Response (DOR) [ Time Frame: First occurrence of a documented objective response to the date of disease progression or death from any cause, whichever occurs first (up to 36 months) ]
IRC-Assessed Disease Control Rate (DCR) [ Time Frame: From randomization up to 36 months ]
Investigator-Assessed Best Clinical Response (BCR) Rate [ Time Frame: From randomization up to 36 months ]
Investigator-Assessed DOR [ Time Frame: First occurrence of a documented objective response to the date of disease progression or death from any cause, whichever occurs first (up to 36 months) ]
IRC-Assessed Progression-Free Survival (PFS) [ Time Frame: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 36 months) ]
IRC-Assessed PFS Rate at 6 Months [ Time Frame: 6 months ]
Overall Survival (OS) [ Time Frame: From randomization to death from any cause (up to 36 months) ]
OS Rate at 6 Months and 12 Months [ Time Frame: 6 months, 12 months ]
Minimum Serum Concentration (Cmin) of Tiragolumab [ Time Frame: Predose and postdose on Day 1 of Cycle 1 (each cycle is 21 days) and predose on Day 1 of Cycles 2, 3, 4, 8, 12 and 16 and at treatment discontinuation (TD) visit (up to 36 months) ]
Maximum Serum Concentration (Cmax) of Tiragolumab [ Time Frame: Predose and postdose on Day 1 of Cycle 1 (each cycle is 21 days) and predose on Day 1 of Cycles 2, 3, 4, 8, 12 and 16 and at TD visit (up to 36 months) ]
Cmin of Atezolizumab [ Time Frame: Predose and postdose on Day 1 of Cycle 1 (each cycle is 21 days) and predose on Day 1 of Cycles 2, 3, 4, 8, 12 and 16 and at TD visit (up to 36 months) ]
Cmax of Atezolizumab [ Time Frame: Predose and postdose on Day 1 of Cycle 1 (each cycle is 21 days) and predose on Day 1 of Cycles 2, 3, 4, 8, 12 and 16 and at TD visit (up to 36 months) ]
Percentage of Participants With Anti-Drug Antibodies (ADAs) to Tiragolumab [ Time Frame: Predose on Day 1 of Cycles (each cycle is 21 days) 1, 2, 3, 4, 8, 12 and 16 and at TD visit (up to 36 months) ]
Percentage of Participants With ADAs to Atezolizumab [ Time Frame: Predose on Day 1 of Cycles (each cycle is 21 days) 1, 2, 3, 4, 8, 12 and 16 and at TD visit (up to 36 months) ]
Independent Review Committee (IRC)-Assessed Objective Response Rate (ORR) [ Time Frame: From randomization up to 36 months ]
Secondary Outcome Measures :
Percentage of Participants With Adverse Events [ Time Frame: Up to 36 months ]
IRC-Assessed Duration of Response (DOR) [ Time Frame: First occurrence of a documented objective response to the date of disease progression or death from any cause, whichever occurs first (up to 36 months) ]
IRC-Assessed Disease Control Rate (DCR) [ Time Frame: From randomization up to 36 months ]
Investigator-Assessed Best Clinical Response (BCR) Rate [ Time Frame: From randomization up to 36 months ]
Investigator-Assessed DOR [ Time Frame: First occurrence of a documented objective response to the date of disease progression or death from any cause, whichever occurs first (up to 36 months) ]
IRC-Assessed Progression-Free Survival (PFS) [ Time Frame: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 36 months) ]
IRC-Assessed PFS Rate at 6 Months [ Time Frame: 6 months ]
Overall Survival (OS) [ Time Frame: From randomization to death from any cause (up to 36 months) ]
OS Rate at 6 Months and 12 Months [ Time Frame: 6 months, 12 months ]
Minimum Serum Concentration (Cmin) of Tiragolumab [ Time Frame: Predose and postdose on Day 1 of Cycle 1 (each cycle is 21 days) and predose on Day 1 of Cycles 2, 3, 4, 8, 12 and 16 and at treatment discontinuation (TD) visit (up to 36 months) ]
Maximum Serum Concentration (Cmax) of Tiragolumab [ Time Frame: Predose and postdose on Day 1 of Cycle 1 (each cycle is 21 days) and predose on Day 1 of Cycles 2, 3, 4, 8, 12 and 16 and at TD visit (up to 36 months) ]
Cmin of Atezolizumab [ Time Frame: Predose and postdose on Day 1 of Cycle 1 (each cycle is 21 days) and predose on Day 1 of Cycles 2, 3, 4, 8, 12 and 16 and at TD visit (up to 36 months) ]
Cmax of Atezolizumab [ Time Frame: Predose and postdose on Day 1 of Cycle 1 (each cycle is 21 days) and predose on Day 1 of Cycles 2, 3, 4, 8, 12 and 16 and at TD visit (up to 36 months) ]
Percentage of Participants With Anti-Drug Antibodies (ADAs) to Tiragolumab [ Time Frame: Predose on Day 1 of Cycles (each cycle is 21 days) 1, 2, 3, 4, 8, 12 and 16 and at TD visit (up to 36 months) ]
Percentage of Participants With ADAs to Atezolizumab [ Time Frame: Predose on Day 1 of Cycles (each cycle is 21 days) 1, 2, 3, 4, 8, 12 and 16 and at TD visit (up to 36 months) ]
Inclution Criteria
Inclusion Criteria:
Histologically confirmed recurrent or persistent squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix after progression on or after 1-2 lines of prior systemic chemotherapy in the metastatic/recurrent setting that is not amenable to curative treatment with systemic chemotherapy, surgery, and/or radiotherapy
Radiologically-measurable disease
Eastern Cooperative Oncology Group (ECOG) performance Status of 0 or 1
Cervical cancer tissue for study analysis (archival or fresh biopsy specimen)
Life expectancy of at least 12 weeks
Adequate hematologic and organ function
Female of childbearing potential must be willing to comply with adequate contraception
Histologically confirmed recurrent or persistent squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix after progression on or after 1-2 lines of prior systemic chemotherapy in the metastatic/recurrent setting that is not amenable to curative treatment with systemic chemotherapy, surgery, and/or radiotherapy
Radiologically-measurable disease
Eastern Cooperative Oncology Group (ECOG) performance Status of 0 or 1
Cervical cancer tissue for study analysis (archival or fresh biopsy specimen)
Life expectancy of at least 12 weeks
Adequate hematologic and organ function
Female of childbearing potential must be willing to comply with adequate contraception
Exclusion Criteria
Exclusion Criteria:
Treatment with investigational therapy with therapeutic intent within 28 days prior to randomization
Active or untreated central nervous system (CNS) or brain metastases
Active or history of autoimmune disease or immune deficiency
Active tuberculosis
Known, clinically significant liver disease
Severe infection per investigator judgement at the time of randomization or any active infection that, in the opinion of the investigator, could impact patient safety
Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti-CTLA-4, anti-TIGIT, anti-PD-1, and anti-PD-L1 therapeutic antibodies
Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to randomization
Treatment with systemic immunosuppressive medications within 1 week prior to randomization or anticipation of need for systemic immunosuppressive medication during study
Pregnant or breastfeeding woman
Known hypersensitivity to any component of the tiragolumab or atezolizumab formulations
Treatment with investigational therapy with therapeutic intent within 28 days prior to randomization
Active or untreated central nervous system (CNS) or brain metastases
Active or history of autoimmune disease or immune deficiency
Active tuberculosis
Known, clinically significant liver disease
Severe infection per investigator judgement at the time of randomization or any active infection that, in the opinion of the investigator, could impact patient safety
Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti-CTLA-4, anti-TIGIT, anti-PD-1, and anti-PD-L1 therapeutic antibodies
Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to randomization
Treatment with systemic immunosuppressive medications within 1 week prior to randomization or anticipation of need for systemic immunosuppressive medication during study
Pregnant or breastfeeding woman
Known hypersensitivity to any component of the tiragolumab or atezolizumab formulations
The Estimated Number of Participants
-
Taiwan
30 participants
-
Global
160 participants
