Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2019-004895-21 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tiragolumab plus Atezolizumab | Experimental | Participants will receive tiragolumab and atezolizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator. |
|
| Atezolizumab | Experimental | Participants will receive atezolizumab monotherapy until unacceptable toxicity or loss of clinical benefit as determined by the investigator. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tiragolumab | Drug | Tiragolumab at a fixed dose of 600 milligrams (mg) will be administered by intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pre-crossover Period: Independent Review Committee (IRC)-Assessed Objective Response Rate (ORR) | ORR was defined as the percentage of participants with a complete response (CR) or a partial response (PR) on two consecutive occasions ≥4 weeks apart, as determined by the IRC according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). CR=Disappearance of all target & non-target lesions or any pathological lymph nodes (whether target or non-target) have reduction in short axis to <10 millimeters (mm). PR=At least a 30% decrease in the sum of diameters (SOD) of all target lesions, taking as reference the baseline SOD, in the absence of CR. The study enrolled participants with measurable disease as determined by the investigator. Participants found to have non-measurable disease at baseline according to RECIST v1.1 (through IRC assessment or Protocol Deviations) were only considered responders if they achieved a CR. Percentages have been rounded off. | From randomization up to approximately 17 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pre- and Post-crossover Periods: Number of Participants With Adverse Events (AEs) | An AE was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Oncology Associates | Phoenix | Arizona | 85016 | United States | ||
| Kaiser Permanente - Irvine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38858106 | Derived | Salani R, McCormack M, Kim YM, Ghamande S, Hall SL, Lorusso D, Barraclough L, Gilbert L, Guzman Ramirez A, Lu CH, Sabatier R, Colombo N, Hu Y, Krishnan V, Molinero L, Feng Y, Kim N, Castro M, Lin YG, Monk BJ. A non-comparative, randomized, phase II trial of atezolizumab or atezolizumab plus tiragolumab for programmed death-ligand 1-positive recurrent cervical cancer (SKYSCRAPER-04). Int J Gynecol Cancer. 2024 Aug 5;34(8):1140-1148. doi: 10.1136/ijgc-2024-005588. |
Not provided
Not provided
For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
Not provided
Not provided
Not provided
Not provided
Participants with programmed death-ligand 1 (PDL1)-positive cervical cancer in the pre-crossover period were randomized in a 3:1 ratio to receive either atezolizumab plus tiragolumab or atezolizumab monotherapy. Participants in the atezolizumab monotherapy arm with unequivocal disease progression (PD) were given the option to crossover and receive atezolizumab + tiragolumab in the crossover period. Crossover was allowed at investigator's discretion, after consultation with Medical Monitor.
A total of 172 participants took part in the study at 59 investigative sites across 17 countries from 30 June 2020 to 24 February 2025. 1 participant was enrolled but not treated.
The study is considered "Completed" because all the pre-planned study activities and analyses have been performed.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Pre-crossover: Atezolizumab Monotherapy | Participants received atezolizumab, 1200 milligrams (mg), as an intravenous (IV) infusion, every 3 weeks (Q3W) on Day 1 of each 21-day cycle until PD, loss of clinical benefit, or unacceptable toxicity as determined by the investigator. |
| FG001 | Pre-crossover: Atezolizumab + Tiragolumab |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Pre-Crossover |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 6, 2023 | Feb 19, 2026 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Atezolizumab | Drug | Atezolizumab at a fixed dose of 1200 mg will be administered by IV infusion Q3W on Day 1 of each 21-day cycle. |
|
|
| Up to approximately 50.3 months |
| Pre-crossover Period: IRC-assessed Duration of Response (DOR) | DOR was defined for participants who had objective response (OR) as time from first occurrence of a documented OR (CR/PR) to date of PD or death from any cause (whichever occurred first), determined by IRC per RECIST v1.1. CR=Disappearance of all target & non-target lesions or any pathological lymph nodes (whether target/non-target) have reduction in short axis to <10 mm. PR=≥30% decrease in SOD of all target lesions, taking as reference baseline SOD, in absence of CR. PD = ≥ 20% increase in SOD of target lesions, taking as reference smallest SOD at prior timepoints (including baseline); in addition to relative increase of 20%, SOD must also demonstrate an absolute increase of ≥5 mm or unequivocal progression in non-target lesion(s). Study enrolled participants with measurable disease as per investigator. Participants who had non-measurable disease at baseline according to RECIST v1.1 (IRC assessment or Protocol Deviations) were only considered responders if they achieved CR. | First occurrence of a documented objective response to the date of PD or death from any cause, whichever occurred first (up to approximately 17 months) |
| Pre-crossover Period: IRC-assessed Disease Control Rate (DCR) | DCR was defined as the percentage of participants with a CR, PR, or stable disease (SD), as determined by the IRC according to RECIST v1.1. CR and PR were defined the same as in the description of primary outcome measure (OM), ORR. SD=Neither sufficient shrinkage to qualify for CR/PR nor sufficient increase to qualify for PD. Participants were classified as SD only if SD was observed on two consecutive assessments ≥6 weeks apart. PD = ≥ 20% increase in SOD of target lesions, taking as reference smallest SOD at prior timepoints (including baseline); in addition to relative increase of 20%, SOD must also demonstrate an absolute increase of ≥5 mm or unequivocal progression in non-target lesion(s). Study enrolled participants with measurable disease as per the investigator. Participants who had non-measurable disease at baseline per RECIST v1.1 (IRC assessment or Protocol Deviations) were only considered responders if they achieved CR. | From randomization up to approximately 17 months |
| Pre-crossover Period: Investigator-assessed Best Clinical Response (BCR) Rate | BCR was defined as the percentage of participants with a CR, PR, or SD, as determined by the investigator according to RECIST v1.1. CR=Disappearance of all target & non-target lesions or any pathological lymph nodes (whether target/non-target) have reduction in short axis to <10 mm. PR=At least a 30% decrease in SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. SD=Neither sufficient shrinkage to qualify for CR/PR nor sufficient increase to qualify for PD. Participants were classified as SD only if SD was observed on two consecutive assessments ≥6 weeks apart. PD=At least 20% increase in SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline); in addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥5 mm or unequivocal progression in non-target lesion(s). Percentages have been rounded off. | From randomization up to approximately 17 months |
| Pre-crossover Period: Investigator-assessed Duration of BCR | Duration of BCR was defined for BCR responders as the time from first occurrence of a documented response (CR, PR, or SD) to date of PD or death from any cause (whichever occurred first), as clinically determined by the investigator according to RECIST v1.1. CR=Disappearance of all target & non-target lesions or any pathological lymph nodes (whether target/non-target) have reduction in short axis to <10 mm. PR = ≥30% decrease in SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. SD=Neither sufficient shrinkage to qualify for CR/PR nor sufficient increase to qualify for PD. Participants were classified as SD only if SD was observed on two consecutive assessments ≥6 weeks apart. PD = ≥20% increase in SOD of target lesions, taking as reference smallest SOD at prior timepoints (including baseline); in addition to relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥5 mm or unequivocal progression in non-target lesion(s). | First occurrence of a documented clinical response to the date of PD or death from any cause, whichever occurred first (up to approximately 17 months) |
| Pre-crossover Period: IRC-assessed Progression-free Survival (PFS) | PFS was defined as the time from randomization to the first occurrence of PD or death from any cause (whichever occurred first), as determined by the IRC according to RECIST v1.1. PD was defined as at least 20% increase in SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline); in addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥5 mm or unequivocal progression in non-target lesion(s). | From randomization to the first occurrence of PD or death from any cause, whichever occurred first (up to approximately 17 months) |
| Pre-crossover Period: IRC-assessed PFS Rate at 6 Months | PFS rate was defined as the percentage of participants who were event-free at 6 months post-randomization, as determined by the IRC according to RECIST v1.1. PFS was defined as the time from randomization to the first occurrence of PD or death from any cause (whichever occurred first), as determined by the IRC according to RECIST v1.1. PD was defined as at least 20% increase in SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline); in addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥5 mm or unequivocal progression in non-target lesion(s).. | At Month 6 |
| Pre-crossover Period: Overall Survival (OS) | OS was defined as the time of randomization to death from any cause. | From randomization to death from any cause (up to approximately 17 months) |
| Pre-crossover Period: OS Rate at 6 Months and 12 Months | OS rate was defined as the percentage of participants who were still alive at 6 months and 12 months. OS was defined as the time of randomization to death from any cause. | At Months 6 and 12 |
| Pre-crossover Period: Minimum Serum Concentration (Cmin) of Tiragolumab | Predose on Day 1 of Cycles 2, 3, 4, 8, 12 and 16 (1 cycle = 21 days) |
| Pre-crossover Period: Maximum Serum Concentration (Cmax) of Tiragolumab | At 30 minutes post-dose on Cycle 1 Day 1 (1 Cycle = 21 days) |
| Pre-crossover Period: Cmin of Atezolizumab | Predose on Day 1 of Cycles 2, 3, 4, 8, 12 and 16 (1 cycle = 21 days) |
| Pre-crossover Period: Cmax of Atezolizumab | At 30 minutes post-dose on Day 1 of Cycle 1 (1 cycle = 21 days) |
| Pre-crossover Period: Percentage of Participants With Anti-Drug Antibodies (ADAs) to Tiragolumab | Participants were considered treatment-emergent ADA-positive if they were ADA negative at baseline or missing data but developed an ADA response following study drug administration (treatment-induced ADA response) or if they were ADA-positive at baseline and the titre of one or more post-baseline samples was at least 4-fold greater (i.e., ≥ 0.60 titre units[t.u]) than the titre of the baseline sample (treatment-enhanced ADA response). | Up to approximately 17 months |
| Pre-crossover Period: Percentage of Participants With ADAs to Atezolizumab | Participants were considered treatment-emergent ADA-positive if they were ADA negative at baseline or missing data but developed an ADA response following study drug administration (treatment-induced ADA response) or if they were ADA-positive at baseline and the titre of one or more post-baseline samples was at least 4-fold greater (i.e., ≥ 0.60 t.u) than the titre of the baseline sample (treatment-enhanced ADA response). Percentages have been rounded off. | Up to approximately 17 months |
| Irvine |
| California |
| 92616 |
| United States |
| Augusta University | Augusta | Georgia | 30912 | United States |
| Oncology Associates of Oregon, P.C | Eugene | Oregon | 97401 | United States |
| Mater Misericordiae Limited | South Brisbane | Queensland | 4101 | Australia |
| Hospital Sao Rafael - HSR | Salvador | Estado de Bahia | 41253-190 | Brazil |
| Hospital Araujo Jorge | Goiânia | Goiás | 74605-070 | Brazil |
| Hospital de Caridade de Ijui | Ijuí | Rio Grande do Sul | 98700-000 | Brazil |
| Hospital Sao Lucas - PUCRS | Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| Hospital Nossa Senhora da Conceicao | Porto Alegre | Rio Grande do Sul | 91350-200 | Brazil |
| Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda | São Paulo | São Paulo | 01317-000 | Brazil |
| Royal Victoria Regional Health Centre | Barrie | Ontario | L4M 6M2 | Canada |
| London Regional Cancer Centre | London | Ontario | N6A 4L6 | Canada |
| Princess Margaret Cancer Center | Toronto | Ontario | M5G 1Z5 | Canada |
| Jewish General Hospital | Montreal | Quebec | H3T 1E2 | Canada |
| McGill University Health Centre - Glen Site | Montreal | Quebec | H4A 3J1 | Canada |
| Clinica CIMCA | San José | 10103 | Costa Rica |
| ICIMED Instituto de Investigación en Ciencias Médicas | San José | 10108 | Costa Rica |
| Centre Leon Berard | Lyon | 69008 | France |
| Institut Paoli Calmettes | Marseille | 13009 | France |
| Centre Régional de Lutte Contre Le Cancer Val D'aurelle Paul Lamarque | Montpellier | 34298 | France |
| ICO - Site René Gauducheau | Saint-Herblain | 44805 | France |
| Gustave Roussy | Villejuif | 94800 | France |
| Istituto Tumori Napoli | Naples | Campania | 80131 | Italy |
| Policlinico Universitario Agostino Gemelli | Rome | Lazio | 00168 | Italy |
| Istituto Europeo Di Oncologia | Milan | Lombardy | 20141 | Italy |
| Christus Muguerza Clinica Vidriera | Monterrey | Nuevo León | 64570 | Mexico |
| Centro Oncológico de Panamá | Panama City | 0801 | Panama |
| The Panama Clinic | Panama City | 0832 | Panama |
| Clinica Ricardo Palma | San Isidro | Lima 27 | Peru |
| Bialostockie Centrum Onkologi | Bialystok | 15-027 | Poland |
| Szpital Morski im.PCK | Gdynia | 81-519 | Poland |
| Narodowy Inst.Onkol.im.Sklodowskiej-Curie Panstw.Inst.Bad Gliwice | Gliwice | 44-101 | Poland |
| Wielkopolskie Centrum Onkologii im. M. Sklodowskiej-Curie | Poznan | 61-866 | Poland |
| Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie | Warsaw | 02-781 | Poland |
| MEDSI Clinical Hospital on Pyatnitsky Highway | Moscow | Moscow Oblast | 143422 | Russia |
| Chelyabisnk regional clinical center for oncology and nuclear medicine | Chelyabinsk | Sverdlovsk Oblast | 454087 | Russia |
| Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic | Kazan' | Tatarstan Republic | 420029 | Russia |
| Tomsk scientific research institute of oncology SO RAMN, PAD | Tomsk | 634050 | Russia |
| Volgograd Regional Clinical Oncology Dispensary | Volgograd | 400138 | Russia |
| Keimyung University Dongsan Hospital | Daegu | 41931 | South Korea |
| Korea Cancer Center Hospital of Korea Institute of Radiological and Medical Sciences | Seoul | 01812 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | 03722 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Gangnam Severance Hospital | Seoul | 06273 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Complejo Hospitalario Universitario A Coruña (CHUAC) | A Coruña | 15006 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Taichung Veterans General Hospital | Taichung | 40705 | Taiwan |
| National Taiwan University Hospital | Taipei | 110 | Taiwan |
| Taipei Veterans General Hospital | Taipei | 11217 | Taiwan |
| Mackay Memorial Hospital | Taipei | Taiwan |
| Chang Gung Medical Foundation, Linkou Branch | Taoyuan City | 333 | Taiwan |
| Maharaj Nakorn Chiang Mai Hospital | Muang | 50200 | Thailand |
| University College London Hospital | London | NW1 - 2PG | United Kingdom |
| Sarah Cannon Research Institute | London | W1G 6AD | United Kingdom |
Participants received atezolizumab, 1200 mg, as an IV infusion Q3W, on Day 1 of each 21-day cycle, followed by tiragolumab, 600 mg, as an IV infusion, Q3W also on Day 1 of each 21-day cycle until PD, loss of clinical benefit, or unacceptable toxicity as determined by the investigator. |
| FG002 | Post Crossover: Atezolizumab + Tiragolumab | Participants in the atezolizumab monotherapy arm with unequivocal PD crossed over & received atezolizumab, 1200 mg, in combination with tiragolumab, 600 mg, as an IV infusion, Q3W on Day 1 of each 21-day cycle until PD, loss of clinical benefit, or unacceptable toxicity as determined by the investigator. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Post-Crossover |
|
|
Treated population included all randomized participants who received at least one dose of the study treatment. Participants were grouped according to the actual treatment received.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pre-crossover: Atezolizumab Monotherapy | Participants received atezolizumab, 1200 mg, as an IV infusion, Q3W on Day 1 of each 21-day cycle until PD, loss of clinical benefit, or unacceptable toxicity as determined by the investigator. |
| BG001 | Pre-crossover: Atezolizumab + Tiragolumab | Participants received atezolizumab, 1200 mg, as an IV infusion Q3W, on Day 1 of each 21-day cycle, followed by tiragolumab, 600 mg, as an IV infusion, Q3W also on Day 1 of each 21-day cycle until PD, loss of clinical benefit, or unacceptable toxicity as determined by the investigator. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| ECOG Performance Status | ECOG Performance Status grades 0 or 1 were used for stratified randomization. Grade 0: Fully active, able to carry on all pre-disease performance without restriction. Grade 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (e.g., light house work, office work). | Count of Participants | Participants |
| |||||||||||||||
| Prior Use of Chemoradiotherapy or Radiotherapy | Prior use of chemotherapy or radiotherapy "yes" or "no" was used for stratified randomization. | Count of Participants | Participants |
| |||||||||||||||
| Treatment History | Treatment history of recurrent versus persistent disease was used for stratified randomization. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pre-crossover Period: Independent Review Committee (IRC)-Assessed Objective Response Rate (ORR) | ORR was defined as the percentage of participants with a complete response (CR) or a partial response (PR) on two consecutive occasions ≥4 weeks apart, as determined by the IRC according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). CR=Disappearance of all target & non-target lesions or any pathological lymph nodes (whether target or non-target) have reduction in short axis to <10 millimeters (mm). PR=At least a 30% decrease in the sum of diameters (SOD) of all target lesions, taking as reference the baseline SOD, in the absence of CR. The study enrolled participants with measurable disease as determined by the investigator. Participants found to have non-measurable disease at baseline according to RECIST v1.1 (through IRC assessment or Protocol Deviations) were only considered responders if they achieved a CR. Percentages have been rounded off. | Treated population included all randomized participants who received at least any dose of study treatment. Participants were grouped according to the actual treatment received. | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization up to approximately 17 months |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Pre- and Post-crossover Periods: Number of Participants With Adverse Events (AEs) | An AE was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. | Treated population included all randomized participants who received at least any dose of study treatment. Participants were grouped according to the actual treatment received. Crossover population included all participants randomized to the atezolizumab monotherapy arm who crossed over to the tiragolumab plus atezolizumab arm, and received at least any dose of tiragolumab after cross-over but not prior to cross-over. | Posted | Count of Participants | Participants | Up to approximately 50.3 months |
| |||||||||||||||||||||||||||||||
| Secondary | Pre-crossover Period: IRC-assessed Duration of Response (DOR) | DOR was defined for participants who had objective response (OR) as time from first occurrence of a documented OR (CR/PR) to date of PD or death from any cause (whichever occurred first), determined by IRC per RECIST v1.1. CR=Disappearance of all target & non-target lesions or any pathological lymph nodes (whether target/non-target) have reduction in short axis to <10 mm. PR=≥30% decrease in SOD of all target lesions, taking as reference baseline SOD, in absence of CR. PD = ≥ 20% increase in SOD of target lesions, taking as reference smallest SOD at prior timepoints (including baseline); in addition to relative increase of 20%, SOD must also demonstrate an absolute increase of ≥5 mm or unequivocal progression in non-target lesion(s). Study enrolled participants with measurable disease as per investigator. Participants who had non-measurable disease at baseline according to RECIST v1.1 (IRC assessment or Protocol Deviations) were only considered responders if they achieved CR. | Treated population included all randomized participants who received at least any dose of study treatment. Participants were grouped according to the actual treatment received. DOR was assessed in participants with an objective response (CR or PR). | Posted | Median | 95% Confidence Interval | months | First occurrence of a documented objective response to the date of PD or death from any cause, whichever occurred first (up to approximately 17 months) |
| ||||||||||||||||||||||||||||||
| Secondary | Pre-crossover Period: IRC-assessed Disease Control Rate (DCR) | DCR was defined as the percentage of participants with a CR, PR, or stable disease (SD), as determined by the IRC according to RECIST v1.1. CR and PR were defined the same as in the description of primary outcome measure (OM), ORR. SD=Neither sufficient shrinkage to qualify for CR/PR nor sufficient increase to qualify for PD. Participants were classified as SD only if SD was observed on two consecutive assessments ≥6 weeks apart. PD = ≥ 20% increase in SOD of target lesions, taking as reference smallest SOD at prior timepoints (including baseline); in addition to relative increase of 20%, SOD must also demonstrate an absolute increase of ≥5 mm or unequivocal progression in non-target lesion(s). Study enrolled participants with measurable disease as per the investigator. Participants who had non-measurable disease at baseline per RECIST v1.1 (IRC assessment or Protocol Deviations) were only considered responders if they achieved CR. | Treated population included all randomized participants who received at least any dose of study treatment. Participants were grouped according to the actual treatment received. | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization up to approximately 17 months |
| ||||||||||||||||||||||||||||||
| Secondary | Pre-crossover Period: Investigator-assessed Best Clinical Response (BCR) Rate | BCR was defined as the percentage of participants with a CR, PR, or SD, as determined by the investigator according to RECIST v1.1. CR=Disappearance of all target & non-target lesions or any pathological lymph nodes (whether target/non-target) have reduction in short axis to <10 mm. PR=At least a 30% decrease in SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. SD=Neither sufficient shrinkage to qualify for CR/PR nor sufficient increase to qualify for PD. Participants were classified as SD only if SD was observed on two consecutive assessments ≥6 weeks apart. PD=At least 20% increase in SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline); in addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥5 mm or unequivocal progression in non-target lesion(s). Percentages have been rounded off. | Treated population included all randomized participants who received at least any dose of study treatment. Participants were grouped according to the actual treatment received. | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization up to approximately 17 months |
| ||||||||||||||||||||||||||||||
| Secondary | Pre-crossover Period: Investigator-assessed Duration of BCR | Duration of BCR was defined for BCR responders as the time from first occurrence of a documented response (CR, PR, or SD) to date of PD or death from any cause (whichever occurred first), as clinically determined by the investigator according to RECIST v1.1. CR=Disappearance of all target & non-target lesions or any pathological lymph nodes (whether target/non-target) have reduction in short axis to <10 mm. PR = ≥30% decrease in SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. SD=Neither sufficient shrinkage to qualify for CR/PR nor sufficient increase to qualify for PD. Participants were classified as SD only if SD was observed on two consecutive assessments ≥6 weeks apart. PD = ≥20% increase in SOD of target lesions, taking as reference smallest SOD at prior timepoints (including baseline); in addition to relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥5 mm or unequivocal progression in non-target lesion(s). | Treated population included all randomized participants who received at least any dose of study treatment. Participants were grouped according to the actual treatment received. Duration of BCR was assessed in participants with a clinical response. | Posted | Median | 95% Confidence Interval | months | First occurrence of a documented clinical response to the date of PD or death from any cause, whichever occurred first (up to approximately 17 months) |
| ||||||||||||||||||||||||||||||
| Secondary | Pre-crossover Period: IRC-assessed Progression-free Survival (PFS) | PFS was defined as the time from randomization to the first occurrence of PD or death from any cause (whichever occurred first), as determined by the IRC according to RECIST v1.1. PD was defined as at least 20% increase in SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline); in addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥5 mm or unequivocal progression in non-target lesion(s). | Treated Population included all randomized participants who received at least any dose of study treatment. Participants were grouped according to the actual treatment received. | Posted | Median | 95% Confidence Interval | months | From randomization to the first occurrence of PD or death from any cause, whichever occurred first (up to approximately 17 months) |
| ||||||||||||||||||||||||||||||
| Secondary | Pre-crossover Period: IRC-assessed PFS Rate at 6 Months | PFS rate was defined as the percentage of participants who were event-free at 6 months post-randomization, as determined by the IRC according to RECIST v1.1. PFS was defined as the time from randomization to the first occurrence of PD or death from any cause (whichever occurred first), as determined by the IRC according to RECIST v1.1. PD was defined as at least 20% increase in SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline); in addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥5 mm or unequivocal progression in non-target lesion(s).. | Treated Population included all randomized participants who received at least any dose of study treatment. Participants were grouped according to the actual treatment received. Overall number analyzed are number of participants with data available for analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | At Month 6 |
| ||||||||||||||||||||||||||||||
| Secondary | Pre-crossover Period: Overall Survival (OS) | OS was defined as the time of randomization to death from any cause. | Treated Population included all randomized participants who received at least any dose of study treatment. Participants were grouped according to the actual treatment received. | Posted | Median | 95% Confidence Interval | months | From randomization to death from any cause (up to approximately 17 months) |
|
| |||||||||||||||||||||||||||||
| Secondary | Pre-crossover Period: OS Rate at 6 Months and 12 Months | OS rate was defined as the percentage of participants who were still alive at 6 months and 12 months. OS was defined as the time of randomization to death from any cause. | Treated Population included all randomized participants who received at least any dose of study treatment. Participants were grouped according to the actual treatment received. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at specified timepoints. | Posted | Number | 95% Confidence Interval | percentage of participants | At Months 6 and 12 |
| ||||||||||||||||||||||||||||||
| Secondary | Pre-crossover Period: Minimum Serum Concentration (Cmin) of Tiragolumab | Pharmacokinetic (PK)-evaluable population included all participants who received any dose of study treatment and who had at least one post-baseline PK sample available. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified time point. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms per milliliter (µg/mL) | Predose on Day 1 of Cycles 2, 3, 4, 8, 12 and 16 (1 cycle = 21 days) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Pre-crossover Period: Maximum Serum Concentration (Cmax) of Tiragolumab | PK-evaluable population included all participants who received any dose of study treatment and who had at least one post-baseline PK sample available. Overall number analyzed is the number of participants with data available for analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | µg/mL | At 30 minutes post-dose on Cycle 1 Day 1 (1 Cycle = 21 days) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Pre-crossover Period: Cmin of Atezolizumab | PK-evaluable population included all participants who received any dose of study treatment and who had at least one post-baseline PK sample available. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified time point. | Posted | Geometric Mean | Geometric Coefficient of Variation | µg/mL | Predose on Day 1 of Cycles 2, 3, 4, 8, 12 and 16 (1 cycle = 21 days) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Pre-crossover Period: Cmax of Atezolizumab | PK-evaluable population included all participants who received any dose of study treatment and who had at least one post-baseline PK sample available. Overall number analyzed is the number of participants with data available for analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | µg/mL | At 30 minutes post-dose on Day 1 of Cycle 1 (1 cycle = 21 days) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Pre-crossover Period: Percentage of Participants With Anti-Drug Antibodies (ADAs) to Tiragolumab | Participants were considered treatment-emergent ADA-positive if they were ADA negative at baseline or missing data but developed an ADA response following study drug administration (treatment-induced ADA response) or if they were ADA-positive at baseline and the titre of one or more post-baseline samples was at least 4-fold greater (i.e., ≥ 0.60 titre units[t.u]) than the titre of the baseline sample (treatment-enhanced ADA response). | ADA-evaluable population included participants with any ADA assessments, with participants grouped according to treatment received. Overall number analyzed is the number of participants with data available for analysis. | Posted | Number | percentage of participants | Up to approximately 17 months |
|
| ||||||||||||||||||||||||||||||
| Secondary | Pre-crossover Period: Percentage of Participants With ADAs to Atezolizumab | Participants were considered treatment-emergent ADA-positive if they were ADA negative at baseline or missing data but developed an ADA response following study drug administration (treatment-induced ADA response) or if they were ADA-positive at baseline and the titre of one or more post-baseline samples was at least 4-fold greater (i.e., ≥ 0.60 t.u) than the titre of the baseline sample (treatment-enhanced ADA response). Percentages have been rounded off. | ADA-evaluable population included participants with any ADA assessments, with participants grouped according to treatment received. Overall number analyzed is the number of participants with data available for analysis. | Posted | Number | percentage of participants | Up to approximately 17 months |
|
Up to approximately 50.3 months
Treated Population included all randomized participants who received at least one dose of study treatment. Participants were grouped according to the actual treatment received. Crossover population included all participants randomized to the atezolizumab monotherapy arm who crossed over to the tiragolumab plus atezolizumab arm, and received at least any dose of tiragolumab after cross-over but not prior to cross-over.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pre-crossover: Atezolizumab Monotherapy | Participants received atezolizumab, 1200 mg, as an IV infusion, Q3W on Day 1 of each 21-day cycle until PD, loss of clinical benefit, or unacceptable toxicity as determined by the investigator. | 23 | 45 | 12 | 45 | 36 | 45 |
| EG001 | Pre-crossover: Atezolizumab + Tiragolumab | Participants received atezolizumab, 1200 mg, as an IV infusion Q3W, on Day 1 of each 21-day cycle, followed by tiragolumab, 600 mg, as an IV infusion, Q3W also on Day 1 of each 21-day cycle until PD, loss of clinical benefit, or unacceptable toxicity as determined by the investigator. | 89 | 126 | 42 | 126 | 109 | 126 |
| EG002 | Post Crossover: Atezolizumab + Tiragolumab | Participants in the atezolizumab monotherapy arm with unequivocal PD crossed over & received atezolizumab, 1200 mg, in combination with tiragolumab, 600 mg, as an IV infusion, Q3W on Day 1 of each 21-day cycle until PD, loss of clinical benefit, or unacceptable toxicity as determined by the investigator. | 10 | 17 | 1 | 17 | 14 | 17 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Ileal stenosis | Gastrointestinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Hyperpyrexia | General disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Autoimmune hepatitis | Hepatobiliary disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Sarcoidosis | Immune system disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Encephalitis | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Enterococcal sepsis | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Pelvic abscess | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Pyelitis | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Systematic Assessment |
| |
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA Version 27.1 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.1 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Device occlusion | Product Issues | MedDRA Version 27.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Pyelocaliectasis | Renal and urinary disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Female genital tract fistula | Reproductive system and breast disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Raynaud's phenomenon | Vascular disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Dilated cardiomyopathy | Cardiac disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Myocarditis | Cardiac disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Hypophysitis | Endocrine disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Abdominal sepsis | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Candida sepsis | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Helicobacter gastritis | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Pneumonia necrotising | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Pulmonary sepsis | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Middle cerebral artery stroke | Nervous system disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Genital haemorrhage | Reproductive system and breast disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Iliac vein occlusion | Vascular disorders | MedDRA Version 27.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Face oedema | General disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Blood magnesium increased | Investigations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Blood sodium decreased | Investigations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Superficial vein thrombosis | Vascular disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Eyelids pruritus | Eye disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Vascular device occlusion | General disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Biliary obstruction | Hepatobiliary disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Systematic Assessment |
| |
| Blood bicarbonate decreased | Investigations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Platelet count increased | Investigations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Urine output decreased | Investigations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Hypervolaemia | Metabolism and nutrition disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Vaginal discharge | Reproductive system and breast disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Vulvovaginal pruritus | Reproductive system and breast disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA Version 27.1 | Systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800 821-8590 | genentech@druginfo.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 17, 2021 | Dec 2, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000730814 | Tiragolumab |
| C000594389 | atezolizumab |
Not provided
Not provided
Not provided
| Lost to Follow-up |
|
| Study Ended by Sponsor |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| ECOG Performance Status 1 |
|
| No |
|
| Persistent Disease |
|
| OG002 | Post Crossover: Atezolizumab + Tiragolumab | Participants in the atezolizumab monotherapy arm with unequivocal PD crossed over & received atezolizumab, 1200 mg, in combination with tiragolumab, 600 mg, as an IV infusion, Q3W on Day 1 of each 21-day cycle until PD, loss of clinical benefit, or unacceptable toxicity as determined by the investigator. |
|
|
| OG001 | Pre-crossover: Atezolizumab + Tiragolumab | Participants received atezolizumab, 1200 mg, as an IV infusion Q3W, on Day 1 of each 21-day cycle, followed by tiragolumab, 600 mg, as an IV infusion, Q3W also on Day 1 of each 21-day cycle until PD, loss of clinical benefit, or unacceptable toxicity as determined by the investigator. |
|
|
| Pre-crossover: Atezolizumab + Tiragolumab |
Participants received atezolizumab, 1200 mg, as an IV infusion Q3W, on Day 1 of each 21-day cycle, followed by tiragolumab, 600 mg, as an IV infusion, Q3W also on Day 1 of each 21-day cycle until PD, loss of clinical benefit, or unacceptable toxicity as determined by the investigator. |
|
|
| Pre-crossover: Atezolizumab + Tiragolumab |
Participants received atezolizumab, 1200 mg, as an IV infusion Q3W, on Day 1 of each 21-day cycle, followed by tiragolumab, 600 mg, as an IV infusion, Q3W also on Day 1 of each 21-day cycle until PD, loss of clinical benefit, or unacceptable toxicity as determined by the investigator. |
|
|
| OG001 | Pre-crossover: Atezolizumab + Tiragolumab | Participants received atezolizumab, 1200 mg, as an IV infusion Q3W, on Day 1 of each 21-day cycle, followed by tiragolumab, 600 mg, as an IV infusion, Q3W also on Day 1 of each 21-day cycle until PD, loss of clinical benefit, or unacceptable toxicity as determined by the investigator. |
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
|
|
|
|