anti-PD-L1 antibody · antibody

atezolizumab

27 active trials across 16 of our biomarkers, targeting PD-L1. 3 active approvals for a biomarker on marked.bio.

Also known as MPDL3280A, RG7446, Tecentriq.

Counts only trials that select patients by one of the biomarkers on marked.bio, not every trial of this drug.

Approvals and pivotal results

Biomarker-selected approvals in the United States and the European Union, with the pivotal trial's results and side effects where we have them. Results from different trials are not directly comparable.

TherapyBiomarkerTumourUnited StatesEuropean Union
atezolizumab with cobimetinib + vemurafenib
FDA, 2020
unresectable or metastatic, BRAF V600 mutation-positive Label 1.4: BRAF V600 mutation-positive. No EU equivalent. Year confirmed: FDA approval announced 30/07/2020. Source
FDA, 2024
unresectable or metastatic, BRAF V600 mutation-positive Subcutaneous atezolizumab approved 12/09/2024 for all adult IV Tecentriq indications, including melanoma; label 1.4. Source
Tecentriq, Tecentriq HybrezaBroader labelcobimetinib pagevemurafenib page
BRAF V600E melanoma Approved 2020 Not approved

IMspire150 vs placebo + cobimetinib + vemurafenib, 514 randomised
PFS 15.1 months vs 10.6 months, HR 0.78 (0.63-0.97)

Trial details and side effects
Patients
first-line BRAF V600 melanoma (NCT02908672)
Most common side effects
rash, musculoskeletal pain, nausea, fatigue, hepatotoxicity, pyrexia
Notes
Atezolizumab added to cobimetinib and vemurafenib. From the FDA approval notice.
Source
FDA approval summary
atezolizumab with fluoropyrimidine + oxaliplatin
FDA, 2026
adjuvant, stage III dMMR colon cancer, adults and children >=2 years FDA approval 08/10/2026; not yet on the DailyMed label (revised 5/2026). Source
Tecentriq
MSI-H / dMMR colon Approved 2026 Not approved

ATOMIC vs mFOLFOX6 alone, 712 randomised
DFS not reached vs not reached, HR 0.50 (0.35-0.73)

Trial details and side effects
Patients
resected stage III dMMR colon cancer (NCT02912559)
Notes
Atezolizumab with mFOLFOX6, then atezolizumab. Disease-free survival. Approved 8 October 2026.
Source
US approval report

Biomarkers

BiomarkerActive trialsAll trialsFurthest active phase
MSI-H / dMMR 8 14 Phase 2/3
BRAF V600E 6 13 Phase 2
BRCA1/2 mutation 5 7 Phase 2
KRAS G12C 4 5 Phase 2
EGFR exon 19 deletion / L858R 3 16 Phase 2
HER2 (ERBB2) activating mutation 3 3 Phase 3
PIK3CA activating mutation 3 4 Phase 1/2
ALK fusion 2 9 Phase 2
ROS1 fusion 2 2 Phase 2
FGFR2 fusion or rearrangement 1 4 Phase 2
KRAS G12D 1 2 Phase 2
NTRK1/2/3 fusion 1 2 Phase 2
RET fusion or mutation 1 3 Phase 2
FGFR3 alteration (mutation or fusion) 0 2 –
FLT3 mutation (ITD/TKD) 0 1 –
MET exon 14 skipping 0 1 –

Sponsors

Industry sponsors leading active biomarker-selected trials of atezolizumab.

  1. Roche 3
  2. Exelixis 2
  3. Amgen 1
  4. Boehringer Ingelheim 1

Trials

Status

27 of 60 trials shown

  1. Beamion LUNG-3: Adjuvant Zongertinib vs Standard Treatment in People With Completely Resected Stage II-IIIB NSCLC Harboring Activating HER2 TKD Mutations

    Recruiting Phase 3 Boehringer Ingelheim Started 2026Primary completion 2032-02 NCT07195695

    zongertinib FDApembrolizumabatezolizumabdurvalumabnivolumab

    HER2 mutation: Documented Tyrosine kinase domain (TKD) activating Human epidermal growth factor recepto…

    HER2 (ERBB2) activating mutationNon-small Cell Lung Cancer

  2. DETERMINE Trial Treatment Arm 02: Atezolizumab in Adult, Paediatric and Teenage/Young Adult Patients With Cancers With High Tumour Mutational Burden (TMB) or Microsatellite Instability-high (MSI-high) or Proven Constitutional Mismatch Repair Deficiency (CMMRD) Disposition

    Recruiting Phase 2/3 Cancer Research UK Started 2023Primary completion 2029-10 NCT05770102

    atezolizumab FDA

    Confirmed diagnosis of a malignancy that is high TMB (defined as ≥10 mut/Mb), MSI-high or of proven (previously diagnosed) CMMRD disposition using an analytically validated nex…

    MSI-H / dMMRMalignancy, Malignant Neoplasm, Lymphoproliferative Disorders, Neoplasms by Histologic Type

  3. Study of XL092 + Atezolizumab vs Regorafenib in Participants With Metastatic Colorectal Cancer

    Active, not recruiting Phase 3 Exelixis Started 2022Primary completion 2026-06 NCT05425940

    zanzalintinibatezolizumab FDAregorafenib

    Documented NOT to have microsatellite instability-high (MSI-high) or mismatch repair deficient (dMMR) CRC by tissue-based analysis.

    MSI-H / dMMRColorectal Cancer

  4. Testing the Addition of Atezolizumab to Combination Chemotherapy or Atezolizumab Alone for Metastatic Colon or Rectal Cancer, the COMMIT Study

    Active, not recruiting Phase 3 National Cancer Institute (NCI) Started 2018Primary completion 2027-06 NCT02997228

    atezolizumab FDAbevacizumabfluorouracilleucovorinoxaliplatin

    Tumor determined to be mismatch-repair deficient (dMMR) by Clinical Laboratory Improvement Act (CLIA)-certified immunohistochemical (IHC) …

    MSI-H / dMMRMetastatic Colorectal Adenocarcinoma, Stage IV Colorectal Cancer AJCC v7

  5. Combination Chemotherapy With or Without Atezolizumab in Treating Patients With Stage III Colon Cancer and Deficient DNA Mismatch Repair

    Active, not recruiting Phase 3 National Cancer Institute (NCI) Started 2017Primary completion 2025-02 NCT02912559

    atezolizumab FDAfluorouracilleucovorinoxaliplatin

    Presence of deficient (d) DNA mismatch repair (dMMR)

    MSI-H / dMMRColon Adenocarcinoma, DNA Repair Disorder, Lynch Syndrome, Stage III Colon Cancer AJCC v8

  6. Clinical Trial for Safety and Effectiveness Evaluation of Tarlatamab (AMG757) With Etoposide, Carboplatin and Atezolizumab in Transformed Small Cell Lung Cancer Patients From Adenocarcinoma After EGFR TKI Treatment

    Recruiting Phase 2 Sehhoon Park Started 2025Primary completion 2027-03 NCT06830694

    atezolizumabetoposidecarboplatin

    Patient initially diagnosed with activating EGFR mutation (L858R, Del 19) and treated with any kind of EGFR TKI.

    EGFR exon 19 deletion / L858RSmall Cell Carcinoma of Lung

  7. HTL0039732 in Participants With Advanced Solid Tumours

    Recruiting Phase 1/2 Cancer Research UK Started 2023Primary completion 2028-12 NCT05944237

    HTL0039732 Capsulesatezolizumab

    MSS CRC with PIK3CA or HER2 mutation/genetic aberration, and/or other driver mutation/genetic aberration as agreed with the Sp…

    PIK3CA activating mutationHER2 (ERBB2) activating mutationNeoplasms, Prostatic Neoplasms, Castration-Resistant, Stomach Neoplasms, Esophageal Neoplasms

  8. Genomics Guided Targeted Post-neoadjuvant Therapy in Patients With Early Breast Cancer (COGNITION-GUIDE)

    Recruiting Phase 2 German Cancer Research Center Started 2023Primary completion 2030-03 NCT05332561

    atezolizumabinavolisibipatasertibolaparibsacituzumab govitecantrastuzumabpertuzumab

    Arm 6 (Trastuzumab / Pertuzumab, ERBBB): HER2 exon-20 insertion, Activating HER2-mutation

    HER2 (ERBB2) activating mutationBRCA1/2 mutationEarly-stage Breast Cancer

  9. Phase 1/2 Clinical Trial of CP-506 (HAP) in Monotherapy or With Carboplatin or ICI

    Recruiting Phase 1/2 Maastricht University Medical Center Started 2023Primary completion 2027-02 NCT04954599

    CP-506carboplatinipilimumabnivolumabpembrolizumabatezolizumabavelumabdurvalumabcemiplimab

    BRCA1/2 carriers), dedicated HRD genomic assays (including exome-sequencing) from liquid or tissue biopsie…

    BRCA1/2 mutationUnspecified Adult Solid Tumor, Protocol Specific

  10. Testing Immunotherapy (Atezolizumab) With or Without Chemotherapy in Locoregional MSI-H/dMMR Gastric and Gastroesophageal Junction (GEJ) Cancer

    Active, not recruiting Phase 2 National Cancer Institute (NCI) Started 2023Primary completion 2026-01 NCT05836584

    atezolizumab FDAcapecitabinedocetaxelfluorouracilleucovorinoxaliplatin

    …ically confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma that is MSI-H/dMMR (microsatellite instability-high/mismatch repair deficient) as determined by one of …

    MSI-H / dMMRClinical Stage I Gastric Cancer AJCC v8, Clinical Stage I Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage II Gastric Cancer AJCC v8, Clinical Stage II Gastroesophageal Junction Adenocarcinoma AJCC v8

  11. Treatment of Atezolizumab and Derazantinib in Patients With Advanced iCCA With FGFR2 Fusions/Rearrangements

    Active, not recruiting Phase 2 Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest Started 2022Primary completion 2025-12 NCT05174650

    atezolizumabderazantinib

    Histologically documented diagnosis of non-resectable iCCA with positively confirmed FGFR2 fusion/rearrangement via NGS-Analysis.

    FGFR2 fusion or rearrangementIntrahepatic Cholangiocarcinoma

  12. Tiragolumab With Atezolizumab Plus Bevacizumab in Previously-Treated Advanced Non-squamous NSCLC

    Active, not recruiting Phase 2 Georgetown University Started 2021Primary completion 2026-11 NCT04958811

    tiragolumabatezolizumabbevacizumab

    Confirmed activating alteration in EGFR (cohort B only)

    EGFR exon 19 deletion / L858RNon-squamous Non-small-cell Lung Cancer

  13. PALbociclib Endocrine Therapy Followed by Talazo Vs. Talazoz-Atezo Study

    Recruiting Phase 2 Samsung Medical Center Started 2021Primary completion 2025-12 NCT04819243

    talazoparib FDA EUatezolizumab

    Confirmed germline pathogenic BRCA1 and/or BRCA2 mutation or 35 HRD-related gene alterations (see Appendix 16.5)

    BRCA1/2 mutationPremenopausal HR+/HER2- Metastatic Breast Cancer

  14. Atezolizumab in Patients With MSI-h/MMR-D Stage II High Risk and Stage III Colorectal Cancer Ineligible for Oxaliplatin

    Active, not recruiting Phase 2 AIO-Studien-gGmbH Started 2021Primary completion 2027-04 NCT05118724

    atezolizumab FDAIMM-101

    Tumor is MSI-high (MSI-H) or MMR-deficient (dMMR) For the main study: assessed from biopsy or from resected…

    MSI-H / dMMRColorectal Cancer

  15. PLATFORM Study of Precision Medicine for Rare Tumors

    Recruiting Phase 2 Cancer Institute and Hospital, Chinese Academy of Medical Sciences Started 2020Primary completion 2026-07 NCT04423185

    aumolertinibdacomitinib FDA EUalectinibcrizotinibpyrotinibimatinibniraparibpalbociclibvemurafenibsintilimabatezolizumab

    when obtaining EGFR mutation, ALK fusion, ROS-1 fusion, C-MET amplification, C-MET mutation, BRAF mutation, BRCA1/2 mu…

    EGFR exon 19 deletion / L858RBRAF V600EBRCA1/2 mutationALK fusionROS1 fusionRare Tumor

  16. A Study of Multiple Therapies in Biomarker-selected Participants With Resectable Stages IB-III Non-small Cell Lung Cancer (NSCLC)

    Recruiting Phase 2 Roche Started 2020Primary completion 2026-11 NCT04302025

    alectinibentrectinibvemurafenibcobimetinibpralsetinibatezolizumabSBRTChemotherapydivarasib

    …on in ≥ 1% tumor cells as determined by Food and Drug Administration (FDA)-approved test, KRAS G12C mutation

    KRAS G12CBRAF V600EALK fusionROS1 fusionRET fusion or mutationNTRK1/2/3 fusionNon-small Cell Lung Cancer

  17. Combination or Sequence of Vemurafenib, Cobimetinib, and Atezolizumab in High-risk, Resectable Melanoma

    Active, not recruiting Phase 2 Fondazione Melanoma Onlus Started 2020Primary completion 2023-12 NCT04722575

    cobimetinib FDA EUvemurafenib FDA EUatezolizumab FDA

    …urafenib, cobImetinib, and atezolizuMab in Patients With High-risk, Surgically Resectable BRAF Mutated and Wild-type Melanoma"

    BRAF V600EMelanoma

  18. Atezolizumab and Cobimetinib in Treating Patients With Metastatic, Recurrent, or Refractory Non-small Cell Lung Cancer

    Active, not recruiting Phase 2 National Cancer Institute (NCI) Started 2018Primary completion 2025-07 NCT03600701

    atezolizumabcobimetinib

    Presence of a mutation in KRAS as detected by a Clinical Laboratory Improvement Act (CLIA)-approved assay is required fo…

    KRAS G12CKRAS G12DMetastatic Lung Non-Small Cell Carcinoma, Recurrent Lung Non-Small Cell Carcinoma, Refractory Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8

  19. A Trial of Ipatasertib in Combination With Atezolizumab

    Active, not recruiting Phase 1/2 Institute of Cancer Research, United Kingdom Started 2018Primary completion 2026-03 NCT03673787

    ipatasertibatezolizumab

    …other aberrations predicted to result in a hyperactivated PI3K-AKT pathway (eg activating mutations in PIK3CA, AKT1, AKT2) or PTEN loss (assessed by immunohistochemistry (IHC) (n=12).

    PIK3CA activating mutationSolid Tumor, Glioblastoma Multiforme, Prostate Cancer Metastatic

  20. Study of Atezolizumab + FLOT vs. FLOT Alone in Patients With GC/GEJ and High Immune Responsiveness

    Active, not recruiting Phase 2 Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest Started 2018Primary completion 2027-05 NCT03421288

    atezolizumab FDAfluorouracilleucovorinoxaliplatindocetaxel

    …[and optional TMB/EBV\] must be performed locally and results for either of the following MSI-high, PD-L1 CPS≥1, TMB ≥10/MB or EBV+ must be available prior to randomization (for details, s…

    MSI-H / dMMRGastric Cancer, Gastroesophageal Junction Adenocarcinoma

  21. Atezolizumab With Chemotherapy in Treating Patients With Anaplastic or Poorly Differentiated Thyroid Cancer

    Active, not recruiting Phase 2 M.D. Anderson Cancer Center Started 2017Primary completion 2027-07 NCT03181100

    atezolizumab FDAbevacizumabcobimetinib FDA EUnab-paclitaxelpaclitaxelvemurafenib FDA EU

    ADDITIONAL INCLUSION CRITERIA FOR BRAF MUTATION (COHORT 1): Patients with a BRAFV600E mutation being considered for the triplet combination (vemurafenib + cobimetinib + atezol…

    BRAF V600EMetastatic Thyroid Gland Carcinoma, Poorly Differentiated Thyroid Gland Carcinoma, Stage IVA Thyroid Gland Anaplastic Carcinoma AJCC v8, Stage IVB Thyroid Gland Anaplastic Carcinoma AJCC v8

  22. Bevacizumab and Atezolizumab With or Without Cobimetinib in Treating Patients With Untreated Melanoma Brain Metastases

    Active, not recruiting Phase 2 M.D. Anderson Cancer Center Started 2017Primary completion 2028-06 NCT03175432

    atezolizumab FDAbevacizumabcobimetinib FDA EU

    Patients that are known to have BRAFV600 mutation must have received prior BRAFi/MEKi prior to enrolling on TACo.

    BRAF V600EBRAF V600 Wild Type, Clinical Stage IV Cutaneous Melanoma AJCC v8, Intracranial Melanoma, Metastatic Malignant Neoplasm in the Brain

  23. Testing Olaparib Either Alone or in Combination With Atezolizumab in BRCA Mutant Non-HER2-positive Breast Cancer

    Active, not recruiting Phase 2 National Cancer Institute (NCI) Started 2017Primary completion 2026-06 NCT02849496

    atezolizumabolaparib FDA EU

    …d unresectable locally advanced or metastatic non-HER2-positive breast cancer and a known BRCA 1/2 mutation present

    BRCA1/2 mutationAnatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Locally Advanced Unresectable Breast Carcinoma, Metastatic Breast Carcinoma

  24. A Study Evaluating Single-agent Inavolisib, Inavolisib Plus Atezolizumab in PIK3CA-Mutated Cancers

    Active, not recruiting Phase 1 Roche Started 2023Primary completion 2027-07 NCT06496568

    inavolisib FDA EUatezolizumab

    A Study Evaluating Single-agent Inavolisib, Inavolisib Plus Atezolizumab in PIK3CA-Mutated Cancers

    PIK3CA activating mutationPIK3CA-Mutated Cancers

  25. A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-6036 Alone or in Combination in Participants With Advanced or Metastatic Solid Tumors With a KRAS G12C Mutation

    Active, not recruiting Phase 1 Roche Started 2020Primary completion 2027-12 NCT04449874

    divarasibatezolizumabcetuximabbevacizumaberlotinibGDC-1971inavolisib

    Histologically documented advanced or metastatic solid tumor with KRAS G12C mutation.

    KRAS G12CNon-Small Cell Lung Cancer, Colorectal Cancer, Advanced Solid Tumors

  26. Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)

    Active, not recruiting Phase 1 Amgen Started 2019Primary completion 2026-12 NCT04185883

    sotorasib FDA EUtrametinibvociprotafibafatinibpembrolizumabpanitumumab FDAcarboplatinpemetrexeddocetaxelpaclitaxelatezolizumabpalbociclib

    Pathologically documented, locally-advanced or metastatic malignancy with, KRAS p.G12C mutation identified through molecular testing performed according to in-country requireme…

    KRAS G12CAdvanced Solid Tumors, Kirsten Rat Sarcoma (KRAS) pG12C Mutation

  27. A Study of XL092 as Single-Agent and Combination Therapy in Subjects With Solid Tumors

    Active, not recruiting Phase 1 Exelixis Started 2019Primary completion 2026-08 NCT03845166

    zanzalintinibatezolizumab FDAavelumab

    BRAF inhibitor (in combination with cetuximab +/- binimetinib) for subjects with BRAF V600E mutations

    BRAF V600EMSI-H / dMMRNeoplasm Malignant, Renal Cell Carcinoma, Hormone Receptor Positive Breast Carcinoma, Metastatic Castration-resistant Prostate Cancer