marked.bio

anti-PD-L1 antibody · antibody

durvalumab

34 active trials across 17 of our biomarkers, targeting PD-L1. 2 active approvals for a biomarker on marked.bio.

Also known as MEDI4736, Imfinzi.

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
durvalumab with carboplatin + paclitaxel, then durvalumab
FDA, 2024
primary advanced or recurrent dMMR FDA approval 14/06/2024. Source
EU (EMA), 2024
primary advanced or recurrent dMMR EU 4.1 checked: durvalumab + carboplatin/paclitaxel then durvalumab monotherapy for dMMR primary advanced or recurrent EC (pMMR patients get durvalumab + olaparib). The EC decision date for this extension could not be found in the procedural-steps documents, so the year is not verified. EC approval reported 08/2024 (Imfinzi + chemotherapy then Imfinzi alone for dMMR). Source
Imfinzi 		MSI-H / dMMR endometrial Approved 2024 Approved 2024

DUO-E (dMMR population) vs placebo + carboplatin + paclitaxel, 95 (dMMR)
PFS not reached vs 7 months, HR 0.42 (0.22-0.80)

Trial details and side effects
Patients
primary advanced or recurrent dMMR endometrial cancer (NCT04269200)
Most common side effects
peripheral neuropathy, musculoskeletal pain, nausea, alopecia, fatigue, abdominal pain
Notes
Durvalumab with chemotherapy, then durvalumab. Overall survival immature at approval.
Source
US approval report

Biomarkers

BiomarkerActive trialsAll trialsFurthest active phase
BRCA1/2 mutation 6 10 Phase 1/2
HER2-low / ultralow (IHC 1+ or 2+/ISH-) 5 5 Phase 2
MSI-H / dMMR 5 13 Phase 3
KRAS G12C 4 8 Phase 3
Claudin 18.2 expression 3 3 Phase 2
FGFR2 fusion or rearrangement 3 3 Phase 2
EGFR exon 19 deletion / L858R 2 9 Phase 3
IDH1/2 mutation 2 2 Phase 2
MET exon 14 skipping 2 2 Phase 2
ALK fusion 1 4 Phase 3
FGFR3 alteration (mutation or fusion) 1 1 Phase 1
HER2 (ERBB2) activating mutation 1 1 Phase 3
KRAS G12D 1 3 Phase 2
PIK3CA activating mutation 1 1 Phase 1
ROS1 fusion 1 2 Phase 3
BRAF V600E 0 1 –
NTRK1/2/3 fusion 0 1 –

Sponsors

Industry sponsors leading active biomarker-selected trials of durvalumab.

  1. AstraZeneca 9
  2. Eli Lilly 2
  3. MSD (Merck & Co.) 1
  4. Boehringer Ingelheim 1
  5. AGO Research 1
  6. Roche 1
  7. I-Mab Biopharma US 1

Trials

34 of 59 trials shown

  1. Tarlatamab and Durvalumab vs. Durvalumab Alone for Limited-Stage-Small Cell Lung Cancer

    Not yet recruiting Phase 3 PrECOG Starts 2027Primary completion 2037-11 NCT07637513

    Tarlatamabdurvalumab

    …previous diagnosis of non-small cell lung cancer (e.g., Epidermal Growth Factor Receptor (EGFR)-mutant non-small cell lung cancer (NSCLC) with SCLC transformation).

    EGFR exon 19 deletion / L858RLimited Stage Small-Cell Lung Cancer

  2. A Clinical Trial of Calderasib (MK-1084) and Durvalumab in People With Non-Small Cell Lung Cancer (MK-1084-015/KANDLELIT-015)

    Recruiting Phase 3 MSD (Merck & Co.) Started 2026Primary completion 2032-12 NCT07554339

    calderasibdurvalumab

    …rvalumab Versus Placebo Plus Durvalumab in Participants With Locally Advanced, Unresected KRAS G12C-Mutant Non-Small Cell Lung Cancer Without Disease Progression Following Definitive Platin…

    KRAS G12CNon-small Cell Lung Cancer

  3. 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

  4. Study of Olomorasib (LY3537982) in Combination With Standard of Care in Participants With Resected or Unresectable KRAS G12C-mutant Non-Small Cell Lung Cancer

    Recruiting Phase 3 Eli Lilly Started 2025Primary completion 2029-05 NCT06890598

    olomorasibpembrolizumabdurvalumab

    Must have disease with evidence of KRAS G12C mutation.

    KRAS G12CCarcinoma, Non-Small-Cell Lung

  5. A Study Evaluating the Efficacy and Safety of Multiple Therapies in Cohorts of Participants With Locally Advanced, Unresectable, Stage III Non-Small Cell Lung Cancer (NSCLC)

    Active, not recruiting Phase 3 Roche Started 2022Primary completion 2030-06 NCT05170204

    alectinib FDA EUentrectinibdurvalumab

    …rformed prior and within 42 days for Cohort A2 (ROS1 positive) and 50 days for Cohort A1 (ALK positive) of the first dose of concurrent chemoradiotherapy (cCRT) or sequential chemoradiotherapy…

    ALK fusionROS1 fusionNon-Small Cell Lung Cancer

  6. Refining Adjuvant Treatment IN Endometrial Cancer Based On Molecular Features

    Recruiting Phase 3 Leiden University Medical Center Started 2021Primary completion 2030-01 NCT05255653

    cisplatincarboplatinpaclitaxeldurvalumab FDA EU

    Molecular classification: MMRd EC

    MSI-H / dMMREndometrial Cancer

  7. Testing the Addition of MEDI4736 (Durvalumab) to Chemotherapy Before Surgery for Patients With High-Grade Upper Urinary Tract Cancer

    Recruiting Phase 2/3 National Cancer Institute (NCI) Started 2021Primary completion 2027-09 NCT04628767

    cisplatindoxorubicindurvalumab FDA EUgemcitabinemethotrexatepegfilgrastimvinblastine

    …l histologic testing of UTUC with additional studies, such as immunohistochemistry and/or microsatellite instability, is strongly recommended to identify patients with high probability of Lynch-related or o…

    MSI-H / dMMRRenal Pelvis and Ureter Urothelial Carcinoma

  8. Alternating Chemo-immunotherapy and FGFR Inhibitor for FGFR-positive Biliary or Cholangiocarcinoma

    Recruiting Phase 2 Ohio State University Comprehensive Cancer Center Started 2026Primary completion 2027-12 NCT07780838

    cisplatindurvalumabgemcitabinepemigatinib FDA EU

    Patients must have tumors classified as having FGFR2 gene fusion/rearrangements or other gain-of function alterations involved in FGFR as detected by any …

    FGFR2 fusion or rearrangementLocally Advanced Ampulla of Vater Carcinoma, Locally Advanced Biliary Tract Carcinoma, Locally Advanced Extrahepatic Cholangiocarcinoma, Locally Advanced Gallbladder Carcinoma

  9. Zolbetuximab, Durvalumab, and FLOT Combination Neoadjuvant Chemotherapy for CLDN18.2-Positive Gastric Cancer or Gastroesophageal Junction Adenocarcinoma

    Recruiting Phase 2 National Cancer Center, Japan Started 2026Primary completion 2030-03 NCT07872722

    zolbetuximab FDA EUdurvalumabfluorouracilleucovorinoxaliplatindocetaxel

    Zolbetuximab, Durvalumab, and FLOT Combination Neoadjuvant Chemotherapy for CLDN18.2-Positive Gastric Cancer or Gastroesophageal Junction Adenocarcinoma

    Claudin 18.2 expressionCLDN18.2-Positive Gastric Cancer, CLDN18.2-Positive Gastroesophageal Junction Adenocarcinoma

  10. Perioperative Therapies in Locally Advanced Unresectable Gastric Cancer

    Recruiting Phase 2 Jeeyun Lee Started 2025Primary completion 2028-10 NCT06630130

    trastuzumab deruxtecancapecitabineRilvegostomigdurvalumabSonesitatug Vedotinoxaliplatin

    In Cohort A＆B, HER2 positive (HER2 IHC 3+ or HER2 IHC 2+/ISH positive) In Cohort C＆D, CLDN18.2 positive

    Claudin 18.2 expressionStomach Neoplasms

  11. A Study to Investigate the Efficacy of Durvalumab Plus Tremelimumab in Combination With Chemotherapy Compared With Pembrolizumab in Combination With Chemotherapy in Metastatic NSCLC Patients With Non-squamous Histology Who Have Mutations and/or Co-mutations in STK11, KEAP1, or KRAS

    Active, not recruiting Phase 2 AstraZeneca Started 2024Primary completion 2026-10 NCT06008093

    durvalumabtremelimumabpemetrexedpembrolizumabcarboplatincisplatin

    Participants must have tumors with STK11 or KEAP1 or KRAS mutations.

    KRAS G12CKRAS G12DCarcinoma, Non-Small-Cell Lung

  12. Pemigatinib Combined With Durvalumab for Previously Treated Biliary Tract Carcinoma

    Not yet recruiting Phase 2 Eastern Hepatobiliary Surgery Hospital Started 2024Primary completion 2026-08 NCT06530823

    pemigatinib FDA EUdurvalumab

    …d, metastatic, or unresectable cholangiocarcinoma or gallbladder cancer confirmed to have FGFR2 fusion or rearrangement;

    FGFR2 fusion or rearrangementStatus may be outdated, last updated 2024-07-31Biliary Tract Carcinoma, Cholangiocarcinoma

  13. Pre-operative Targeted Treatments in Molecularly Selected Resectable Colorectal Cancer (UNICORN)

    Recruiting Phase 2 Gruppo Oncologico del Nord-Ovest Started 2023Primary completion 2027-05 NCT05845450

    trastuzumab deruxtecandurvalumabpanitumumab FDAbotensilimabbalstilimabsotorasib FDA EUVorbipiprantnivolumabamivantamab

    COHORT 8: pMMR/MSS status and KRAS G12C mutation, absence of HER2 overexpression/amplification and wild-type status for BRAF.

    KRAS G12CMSI-H / dMMRColorectal Cancer, Resectable Colorectal Carcinoma

  14. 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

  15. TRUDI: TDXD+Durva in HER2+/Low IBC

    Recruiting Phase 2 Filipa Lynce, MD Started 2023Primary completion 2027-12 NCT05795101

    trastuzumab deruxtecan FDA EUdurvalumab

    HER2-positive status as determined locally by the current ASCO/CAP guidelines or HER2-low tumor expression (IHC 2+/ISH-, IHC 1+/ISH-, or IHC 1+/ISH untested) (note: ISH may be det…

    HER2-low / ultralow (IHC 1+ or 2+/ISH-)Invasive Breast Cancer, Inflammatory Breast Cancer Stage III, HER2-positive Breast Cancer, HER2 Low Breast Adenocarcinoma

  16. WoO: Window of Opportunity Trial of Olaparib and Durvalumab in Histologically Proven EOC

    Recruiting Phase 2 AGO Research Started 2022Primary completion 2028-01 NCT04644289

    olaparib FDA EUdurvalumab

    … epithelial ovarian, fallopian tube or primary peritoneal cancer or known (BReast CAncer) BRCA mutation and any histologic type

    BRCA1/2 mutationEpithelial Ovarian Cancer

  17. Study of Stereotactic Radiosurgery With Olaparib Followed by Durvalumab and Physician's Choice Systemic Therapy in Subjects With Breast Cancer Brain Metastases

    Active, not recruiting Phase 1/2 Colette Shen Started 2022Primary completion 2026-07 NCT04711824

    olaparib FDA EUdurvalumabpaclitaxelnab-paclitaxeleribulincarboplatincisplatincapecitabinegemcitabine

    or 2) HER2-negative (with ER/PR expression \>=10% with germline or somatic BRCA mutation.

    BRCA1/2 mutationBreast Cancer, Brain Metastases, Adult

  18. Savolitinib Combine With Durvalumab in EGFR Wild-type Locally Advanced or Metastatic NSCLC

    Active, not recruiting Phase 2 AstraZeneca Started 2022Primary completion 2027-01 NCT05374603

    savolitinibdurvalumab

    MET Exon 14 skipping mutation, or MET overexpression (IHC 3+ in ≥70% of tumor cells), or MET amplific…

    MET exon 14 skippingLung Cancer

  19. RMT in Combination With Durvalumab + Chemo in Untreated Adenocarcinoma NSCLC. A Randomized Double Blind Phase II Trial

    Recruiting Phase 2 Masonic Cancer Center, University of Minnesota Started 2022Primary completion 2028-01 NCT04105270

    Oral Restorative Microbiota Therapy (RMT) Capsulesdurvalumabcisplatinpemetrexedcarboplatin

    BRAF, RET, NTRK, MET ex 14 splice site mutation

    MET exon 14 skippingAdenocarcinoma of Lung, Lung Cancer

  20. Phase 2 Study of Trastuzumab Deruxtecan in the Neoadjuvant Treatment, or Trastuzumab Deruxtecan Plus Capecitabine Plus Durvalumab(MEDI4736) in the Preoperative and Postoperative Adjuvant Treatment for Patients With HER2 Positive Gastric and Gastroesophageal Junction Adenocarcinoma

    Active, not recruiting Phase 2 National Cancer Center Hospital East Started 2022Primary completion 2028-03 NCT05034887

    trastuzumab deruxtecan FDA EUdurvalumabcapecitabine

    Has HER2 overexpression (IHC3+, or IHC2+ and ISH positive \[FISH or DISH\]). (HER2 Low expression: IHC1+, or IHC2+ and ISH-negative \[FISH or DISH\] with HER2-ECD \> 11.6 ng/mL…

    HER2-low / ultralow (IHC 1+ or 2+/ISH-)Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma

  21. Ph1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2-expressing Gastric Cancer (DESTINY-Gastric03)

    Active, not recruiting Phase 2 AstraZeneca Started 2020Primary completion 2027-05 NCT04379596

    fluorouracilcapecitabinedurvalumaboxaliplatintrastuzumabtrastuzumab deruxtecan FDA EUcisplatinpembrolizumabVolrustomigRilvegostomig

    … 3b,4b and Part 5, pathologically documented adenocarcinoma of the stomach/GEJ/esophagus, HER2-low (IHC 2+/ISH-negative or IHC 1+) based on local tissue testing results

    HER2-low / ultralow (IHC 1+ or 2+/ISH-)Gastric Cancer

  22. Durvalumab, With Olaparib and Fulvestrant in Advanced ER+, HER2- Breast Cancer Patients.

    Active, not recruiting Phase 2 UNICANCER Started 2019Primary completion 2023-11 NCT04053322

    durvalumabolaparib FDA EUfulvestrant

    Documented personal germline alteration in BRCA1 or BRCA2 that is predicted to be deleterious.

    BRCA1/2 mutationER-positive and HER2-negative Metastatic or Locally Advanced Breast Cancer, a Germline or Somatic BRCA Mutation, or a Deleterious Alteration of Other Genes Involved in Homologous Recombination Repair (HRR) or in MSI Status

  23. Study of Olaparib and Durvalumab in IDH-Mutated Solid Tumors

    Active, not recruiting Phase 2 University Health Network, Toronto Started 2019Primary completion 2026-09 NCT03991832

    olaparibdurvalumab

    …ic and oligodendroglial tumors by World Health Organization 2016 classification which are IDH mutant.

    IDH1/2 mutationGlioma, Cholangiocarcinoma, Solid Tumor, IDH Mutation

  24. A Study of Novel Anti-cancer Agents in Patients With Metastatic Triple Negative Breast Cancer

    Active, not recruiting Phase 1/2 AstraZeneca Started 2018Primary completion 2024-11 NCT03742102

    durvalumabcapivasertiboleclumabpaclitaxeltrastuzumab deruxtecan FDA EUdatopotamab deruxtecan

    …provide documentation of locally determined advanced/unresectable or metastatic TNBC with HER2 low tumor expression (IHC 2+/ISH-, IHC 1+/ISH-, or IHC 1+/ISH untested)

    HER2-low / ultralow (IHC 1+ or 2+/ISH-)Triple Negative Breast Neoplasms

  25. Cabozantinib Plus Durvalumab With or Without Tremelimumab in Patients With Gastroesophageal Cancer and Other Gastrointestinal Malignancies

    Recruiting Phase 1/2 Anwaar Saeed Started 2018Primary completion 2028-06 NCT03539822

    cabozantinibdurvalumab FDA EUtremelimumab

    Patients should have known tumor results for microsatellite instability (MSI) or mismatch repair (MMR) proteins.

    MSI-H / dMMRGastric Cancer, Esophageal Adenocarcinoma, Hepatocellular Carcinoma, Colorectal Cancer

  26. Danvatirsen and Durvalumab in Treating Patients With Advanced and Refractory Pancreatic, Non-Small Cell Lung Cancer, and Mismatch Repair Deficient Colorectal Cancer

    Active, not recruiting Phase 2 M.D. Anderson Cancer Center Started 2017Primary completion 2025-08 NCT02983578

    Danvatirsendurvalumab FDA EU

    …reating Patients With Advanced and Refractory Pancreatic, Non-Small Cell Lung Cancer, and Mismatch Repair Deficient Colorectal Cancer

    MSI-H / dMMRAdvanced Colorectal Carcinoma, Advanced Lung Non-Small Cell Carcinoma, Lung Non-Small Cell Carcinoma, Mismatch Repair Deficiency

  27. A Phase I/II Study of MEDI4736 in Combination With Olaparib in Patients With Advanced Solid Tumors.

    Active, not recruiting Phase 1/2 AstraZeneca Started 2016Primary completion 2021-09 NCT02734004

    olaparib FDA EUdurvalumabbevacizumab FDA EU

    gBRCAm HER2-negative metastatic breast cancer (module 2)

    BRCA1/2 mutationOvarian, Breast, SCLC, Gastric Cancers

  28. Study of TJ033721 (Givastomig) in Subjects With Advanced or Metastatic Solid Tumors

    Recruiting Phase 1 I-Mab Biopharma US Started 2021Primary completion 2026-12 NCT04900818

    TJ033721 (givastomig)nivolumabTJ033721 (givastomig), chemotherapydurvalumab

    Must have CLDN18.2-positive tumor expression

    Claudin 18.2 expressionSolid Tumor, Advanced Cancer, Metastatic Cancer, Gastric Cancer

  29. Study of LY3410738 Administered to Patients With Advanced Solid Tumors With IDH1 or IDH2 Mutations

    Active, not recruiting Phase 1 Eli Lilly Started 2020Primary completion 2023-07 NCT04521686

    LY3410738gemcitabinecisplatindurvalumab

    Evidence of IDH1 R132 mutation (any solid tumor) or circulating tumor DNA IDH2 R140 or IDH2 R172 mutation (chol…

    IDH1/2 mutationCholangiocarcinoma, Chondrosarcoma, Glioma, Any Solid Tumor

  30. A Phase 1b Study of T-DXd Combinations in HER2-low Advanced or Metastatic Breast Cancer

    Active, not recruiting Phase 1 AstraZeneca Started 2020Primary completion 2023-08 NCT04556773

    trastuzumab deruxtecan FDA EUdurvalumabpaclitaxelcapivasertibanastrozolefulvestrantcapecitabine

    Has a history of HER2-low expression, defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested) with a validated assay

    HER2-low / ultralow (IHC 1+ or 2+/ISH-)Metastatic Breast Cancer

  31. Testing the Combination of the Anti-cancer Drugs Copanlisib, Olaparib, and MEDI4736 (Durvalumab) in Patients With Advanced Solid Tumors With Selected Mutations

    Active, not recruiting Phase 1 National Cancer Institute (NCI) Started 2019Primary completion 2024-07 NCT03842228

    copanlisibdurvalumabolaparib

    or actionable mutations in the PTEN gene, or hotspot mutations in the PIK3CA gene (E542, E545 or H1047 are accepted).

    PIK3CA activating mutationAdvanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, Unresectable Malignant Solid Neoplasm

  32. Open-Label, Randomised, Multi-Drug, Biomarker-Directed, Phase 1b Study in Pts w/ Muscle Invasive Bladder Cancer

    Active, not recruiting Phase 1 AstraZeneca Started 2016Primary completion 2020-03 NCT02546661

    fexagratinibdurvalumabolaparibadavosertibVistusertibAZD9150selumetinib

    Confirmation of FGFR3 mutation or FGFR fusion

    FGFR3 alteration (mutation or fusion)FGFR2 fusion or rearrangementMuscle Invasive Bladder Cancer

  33. AZD9291 in Combination With Ascending Doses of Novel Therapeutics

    Active, not recruiting Phase 1 AstraZeneca Started 2014Primary completion 2020-03 NCT02143466

    osimertinib FDA EUsavolitinibselumetinibdurvalumab

    …our harbours an EGFR mutation known to be associated with EGFR TKI sensitivity (including exon 19 deletion and L858R).

    EGFR exon 19 deletion / L858RAdvanced Non Small Cell Lung Cancer

  34. Ascending Doses of Ceralasertib in Combination With Chemotherapy and/or Novel Anti Cancer Agents

    Active, not recruiting Phase 1 AstraZeneca Started 2014Primary completion 2025-03 NCT02264678

    ceralasertibolaparib FDA EUdurvalumabsaruparibcarboplatin

    Module 5 Part B: known or suspected BRCA mutation, PALB2 mutation, RAD51C/D mutation or HRD positive status

    BRCA1/2 mutationAdv Solid Malig - H&N SCC, ATM Pro / Def NSCLC, Gastric, Breast and Ovarian Cancer