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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-506184-34-00 | Registry Identifier | CTIS (EU) |
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This is an open-label, multicenter, extension study. Patients who are receiving clinical benefit from atezolizumab monotherapy or atezolizumab in combination with other agent(s) or combination/comparator agent(s) during participation in a Genentech or Roche-sponsored study (the parent study), who are eligible to continue treatment and who do not have access to the study treatment locally, may continue to receive study treatment in this extension study following roll-over from the parent study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atezolizumab Monotherapy | Experimental | Participants will receive atezolizumab by intravenous infusion at a fixed dose of 1200 mg on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. |
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| Combined Agents with Atezolizumab | Experimental | Participants will receive treatment of atezolizumab with combined agent(s) as directed per the parent study. Participants will receive agent(s) in combination with atezolizumab at the same dose and schedule, and with the same administration guidelines that were in effect at the time of participant discontinuation from the parent study. |
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| Comparator Treatment | Active Comparator | Participants will receive comparator treatment administration as directed per the parent study. Participants will receive comparator treatment at the same dose and schedule, and with the same administration guidelines that were in effect at the time of participant discontinuation from the parent study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atezolizumab | Drug | Atezolizumab will be administered as a monotherapy or atezolizumab with other agent(s) as per parent protocol. Dosing regimen will continue in accordance with the parent study or at equivalent dose (if applicable) and at the same schedule as the parent study, or switch to a fixed atezolizumab dose of 1200 mg every 3 weeks (Q3W). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Continued Access to Atezolizumab-Based Therapy and/or Comparator Agent(s) | Day 1 up to maximum 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Serious Adverse Events (SAEs) According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 | Day 1 up to 90 days after last dose of study treatment (last dose=until clinical benefit or until death, withdrawal of consent, unacceptable toxicity, pregnancy, non-compliance, or termination by Sponsor, whichever occurs first) (up to maximum 10 years) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Cancer Center | Aurora | Colorado | 80045 | United States | ||
| Yale University School Of Medicine |
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
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| Bevacizumab | Drug | Bevacizumab will be administered as directed per the parent study. |
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| Alectinib | Drug | Alectinib will be administered as directed per the parent study. |
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| Cobimetinib | Drug | Cobimetinib will be administered as directed per the parent study. |
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| Vemurafenib | Drug | Vemurafenib will be administered as directed per the parent study. |
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| FAP IL2V | Drug | FAP IL2V will be administered as directed per the parent study. |
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| Venetoclax | Drug | Venetoclax will be administered as directed per the parent study. |
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| Enzalutamide | Drug | Enzalutamide will be administered as directed per the parent study. |
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| Pembrolizumab | Drug | Pembrolizumab will be administered as directed per the parent study. |
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| Sunitinib | Drug | Sunitinib will be administered as directed per the parent study. |
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| Niraparib | Drug | Niraparib will be administered as directed per the parent study. |
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| Cabozantinib | Drug | Cabozantinib will be administered as directed per the parent study. |
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| Pemetrexed | Drug | Pemetrexed will be administered as directed per the parent study. |
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| Paclitaxel | Drug | Paclitaxel will be administered as directed per the parent study. |
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| Emactuzumab | Drug | Emactuzumab will be administered as directed per the parent study. |
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| Rucaparib | Drug | Rucaparib will be administered as directed per the parent study. |
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| Percentage of Participants With Adverse Events of Special Interest Determined According to NCI CTCAE Version 5.0 | Day 1 up to 90 days after last dose of study treatment (last dose=until clinical benefit or until death, withdrawal of consent, unacceptable toxicity, pregnancy, non-compliance, or termination by Sponsor, whichever occurs first) (up to maximum 10 years) |
| Treatment Duration | Day 1 up to 90 days after last dose of study treatment (last dose=until clinical benefit or until death, withdrawal of consent, unacceptable toxicity, pregnancy, non-compliance, or termination by Sponsor, whichever occurs first) (up to maximum 10 years) |
| Total Dose Received | Day 1 up to 90 days after last dose of study treatment (last dose=until clinical benefit or until death, withdrawal of consent, unacceptable toxicity, pregnancy, non-compliance, or termination by Sponsor, whichever occurs first) (up to maximum 10 years) |
| Number of Treatment Cycles | Day 1 up to 90 days after last dose of study treatment (last dose=until clinical benefit or until death, withdrawal of consent, unacceptable toxicity, pregnancy, non-compliance, or termination by Sponsor, whichever occurs first) (up to maximum 10 years) |
| Trumbull |
| Connecticut |
| 06611 |
| United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Carolina BioOncology Institute, PLCC | Huntersville | North Carolina | 28078 | United States |
| St. Luke's Cancer Care Associates | Bethlehem | Pennsylvania | 18015 | United States |
| University of Texas Health Sciences Center in San Antonio | San Antonio | Texas | 78229 | United States |
| St Vincent'S Hospital | Darlinghurst | New South Wales | 2010 | Australia |
| UZ Leuven | Leuven | Flemish Brabant | 3000 | Belgium |
| Institut Jules Bordet | Brussels | 1000 | Belgium |
| UZ Brussel | Brussels | 1090 | Belgium |
| Hospital das Clinicas - UFRGS | Porto Alegre | Rio Grande do Sul | Brazil |
| Multiprofile Hospital for Active Treatment Central Onco Hospital OOD | Plovdiv | 4004 | Bulgaria |
| Pontificia Universidad Catolica de Chile | Santiago | 8330032 | Chile |
| Masaryk?v onkologický ústav | Brno | 656 53 | Czechia |
| Rigshospitalet | København Ø | 2100 | Denmark |
| CHU Angers | Angers | Pays de la Loire Region | 49933 | France |
| Centre Antoine Lacassagne | Nice | Provence-Alpes-Côte d'Azur Region | 06189 | France |
| Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez | Lille | 59037 | France |
| hopital de la Timone | Marseille | 13005 | France |
| Institut Gustave Roussy | Villejuif | Île-de-France Region | 94805 | France |
| Universitätsklinikum Ulm | Ulm | Baden-Wurttemberg | 89081 | Germany |
| Krankenhaus Barmherzige Bruder Regensburg | Regensburg | Bavaria | 93049 | Germany |
| Universitätsklinikum Schleswig-Holstein;Campus Lübeck | Lübeck | Schleswig-Holstein | 23538 | Germany |
| Kliniken Essen-Mitte | Essen | 45136 | Germany |
| Universitätsklinikum Freiburg | Freiburg im Breisgau | 79106 | Germany |
| Asklepios-Fachklinik Muenchen-Gauting | Gauting | 82131 | Germany |
| SRH Wald-Klinikum Gera | Gera | 07548 | Germany |
| HOPA MVZ GmbH | Hamburg | 22767 | Germany |
| Lungenfachklinik Immenhausen | Immenhausen | 34376 | Germany |
| Universitaetsklinikum Muenster | Münster | 48149 | Germany |
| Universitaets-Hautklinik Tuebingen | Tübingen | 72076 | Germany |
| Universitaettsklinikum Tübingen | Tübingen | 72076 | Germany |
| Universitätsklinik Tübingen | Tübingen | 72076 | Germany |
| Metropolitan Hospital | Piraeus | Attica | 18547 | Greece |
| Laiko General Hospital Athen | Athens | 115 27 | Greece |
| Anticancer Hospital Ag. Savas | Athens | 11522 | Greece |
| Grupo Angeles | Guatemala City | 01015 | Guatemala |
| Queen Mary Hospital | Hong Kong | Hong Kong |
| Szegedi Tudományegyetem | Szeged | Hungary |
| Istituto Nazionale dei Tumori | Milan | Lombardy | 20133 | Italy |
| Nagoya University Hospital | Aichi | 466-8560 | Japan |
| National Hospital Organization Shikoku Cancer Center | Ehime | 791-0280 | Japan |
| National Hospital Organization Kyushu Medical Center | Fukuoka | 810-8563 | Japan |
| Kyushu University Hospital | Fukuoka | 812-8582 | Japan |
| Hokkaido University Hospital | Hokkaido | 060-8648 | Japan |
| University of Tsukuba Hospital | Ibaraki | 305-8576 | Japan |
| Kanazawa University Hospital | Ishikawa | 920-8641 | Japan |
| Sendai Kousei Hospital | Miyagi | 981-0914 | Japan |
| Niigata University Medical & Dental Hospital | Niigata | 951-8520 | Japan |
| Osaka Habikino Medical Center | Osaka | 583-8588 | Japan |
| NHO Kinki-Chuo Chest Medical Center | Sakaishi | 591-8555 | Japan |
| Phylasis Clinicas Research S de RL de CV | Toluca | 50090 | Mexico |
| Uniwersytecki Szpital Kliniczny w Poznaniu | Pozna? | Greater Poland Voivodeship | 60-569 | Poland |
| Centrum Onkologii im. Prof. F. Lukaszczyka w Bydgoszczy | Bydgoszcz | Kuyavian-Pomeranian Voivodeship | 85-796 | Poland |
| Szpital Specjalistyczny Podkarpacki O?rodek Onkologiczny | Brzozów | 36-200 | Poland |
| Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii | Otwock | 05-400 | Poland |
| Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy | Otwock | 05-400 | Poland |
| Narodowy Instytut Onkologii im. Marii Sk?odowskiej-Curie - Pa?stwowy Instytut Badawczy | Warsaw | 02-781 | Poland |
| Dolnoslaskie Centrum Onkologii | Wroc?aw | 53-412 | Poland |
| Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj Napoca | Cluj-Napoca | 400015 | Romania |
| Centrul de Oncologie Sfantul Nectarie | Craiova | 200347 | Romania |
| Institutul Regional de Oncologie Iasi | Iași | 700483 | Romania |
| Centrul de Oncologie Oncohelp | Timișoara | 300239 | Romania |
| Arkhangelsk Regional Clinical Oncology Dispensary | Arkhangelsk | Arhangelsk | 163045 | Russia |
| Russian Oncology Research Center n.a. N.N. Blokhin | Moscow | Moscow Oblast | 115478 | Russia |
| P.A. Herzen Oncological Inst. | Moscow | Moscow Oblast | 125248 | Russia |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Severance Hospital | Seoul | 03722 | South Korea |
| Asan Medical Center, Uni Ulsan Collegemedicine | Seoul | 138-736 | South Korea |
| Samsung Medical Center | Seoul | 6351 | South Korea |
| Seoul National University College of Medicine, Liver Research Institute | Seoul | South Korea |
| Hospital Universitario Quiron Dexeus | Barcelona | 08028 | Spain |
| Clinica Universidad de Navarra-Madrid | Madrid | 28027 | Spain |
| Hospital Universitario Madrid Sanchinarro | Madrid | 28050 | Spain |
| Faculty of Med. Siriraj Hosp. | Bangkok | 10700 | Thailand |
| Communal Non profit Enterprise Regional Center of Oncology | Kharkiv | Kharkiv Governorate | 61070 | Ukraine |
| National Cancer Institute MOH of Ukraine | Kiev | 36022 | Ukraine |
| ME Kryviy Rih Oncology Dispensary of Dnipropetrovs?k Regional Council | Kryvyi Rih | 50048 | Ukraine |
| Volyn Regional Oncology Dispensary | Lutsk | 43018 | Ukraine |
| Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary | Sumy | 40022 | Ukraine |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000594389 | atezolizumab |
| D000068258 | Bevacizumab |
| C582670 | alectinib |
| C574276 | cobimetinib |
| D000077484 | Vemurafenib |
| C579720 | venetoclax |
| C540278 | enzalutamide |
| C582435 | pembrolizumab |
| D000077210 | Sunitinib |
| C545685 | niraparib |
| C558660 | cabozantinib |
| D000068437 | Pemetrexed |
| D017239 | Paclitaxel |
| C000602304 | emactuzumab |
| C531549 | rucaparib |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000600 | Amino Acids, Dicarboxylic |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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