Bristol Myers Squibb

Biomarkers

• KRAS G12C8
• EGFR exon 19 deletion / L858R3
• ROS1 fusion3
• ALK fusion2
• NTRK1/2/3 fusion2
• MET exon 14 skipping1
• MSI-H / dMMR1

Drugs in these trials

Targeted, immune and antibody-drug-conjugate therapies named in the company's active biomarker-selected trials (including other companies' drugs used in combination).

adagrasib 8pembrolizumab 6cetuximab 5izalontamab brengitecan 3repotrectinib 3nivolumab 3osimertinib 2crizotinib 1ipilimumab 1bevacizumab 1pumitamig 1afatinib 1elzovantinib 1

Upcoming readouts

Active phase 2 and 3 trials whose primary completion date falls in the next 12 months, according to the sponsor.

• 2026-10 Trial of Two Adagrasib Dosing Regimens in NSCLC With KRAS G12C Mutation (KRYSTAL 21) Phase 2 · KRAS G12C
• 2027-02 A Study of Repotrectinib Versus Crizotinib in Participants With Locally Advanced or Metastatic Tyrosine Kinase Inhibitor (TKI)-naïve ROS1-positive Non-Small Cell Lung Cancer (NSCLC) (TRIDENT-3) Phase 3 · ROS1 fusion

Trials

18 of 50 trials shown

1. Study of Izalontamab Brengitecan (BMS-986507) in Combination With Osimertinib Versus Osimertinib Monotherapy or Osimertinib in Combination With Platinum-based Chemotherapy for EGFRmt Non-small Cell Lung Cancer (IZABRIGHT-Lung02)

   Recruiting Phase 3 Bristol Myers Squibb Started 2026Primary completion 2031-12 NCT07680790

   izalontamab brengitecanosimertinib FDA EUpemetrexedcarboplatincisplatin

   Participants must have documented EGFR-TKI-sensitizing mutation (exon 19 deletion or exon 21 L858R substitution)

   EGFR exon 19 deletion / L858RNon-Small Cell Lung Cancer

2. Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy (IZABRIGHT-Lung01)

   Recruiting Phase 2/3 Bristol Myers Squibb Started 2025Primary completion 2028-12 NCT07100080

   izalontamab brengitecancarboplatincisplatinpemetrexed

   Documented evidence of EGFR mutation (exon 19 deletion, L858R mutation).

   EGFR exon 19 deletion / L858RNon-Small Cell Lung Cancer

3. A Study of Adagrasib Plus Pembrolizumab Plus Chemotherapy vs. Placebo Plus Pembrolizumab Plus Chemotherapy in Participants With Previously Untreated Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (KRYSTAL-4)

   Recruiting Phase 3 Bristol Myers Squibb Started 2025Primary completion 2029-09 NCT06875310

   adagrasib FDA EUpembrolizumabcarboplatinpemetrexedcisplatin

   …istologically or cytologically confirmed diagnosis of non-squamous NSCLC with evidence of KRAS G12C mutation via tumor sample and/or circulating tumor deoxyribonucleic acid (ctDNA).

   KRAS G12CCarcinoma, Non-Small-Cell Lung

4. A Study of Repotrectinib Versus Crizotinib in Participants With Locally Advanced or Metastatic Tyrosine Kinase Inhibitor (TKI)-naïve ROS1-positive Non-Small Cell Lung Cancer (NSCLC) (TRIDENT-3)

   Active, not recruiting Phase 3 Bristol Myers Squibb Started 2023Primary completion 2027-02 NCT06140836

   repotrectinib FDA EUcrizotinib FDA EU

   Participant has a ROS1 gene rearrangement/fusion as detected by a local test.

   ROS1 fusionCarcinoma, Non-Small-Cell Lung

5. Phase 3 Study of MRTX849 With Cetuximab vs Chemotherapy in Patients With Advanced Colorectal Cancer With KRAS G12C Mutation (KRYSTAL-10)

   Active, not recruiting Phase 3 Bristol Myers Squibb Started 2021Primary completion 2026-01 NCT04793958

   adagrasib FDA EUcetuximabmFOLFOX6FOLFIRI

   Histologically confirmed diagnosis of colorectal carcinoma with KRAS G12C mutation in tumor tissue.

   KRAS G12CAdvanced Colorectal Cancer, Metastatic Colorectal Cancer

6. Phase 3 Study of MRTX849 (Adagrasib) vs Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation

   Active, not recruiting Phase 3 Bristol Myers Squibb Started 2021Primary completion 2023-12 NCT04685135

   adagrasib FDA EUdocetaxel

   Histologically or cytologically confirmed diagnosis of NSCLC with KRAS G12C mutation.

   KRAS G12CMetastatic Non Small Cell Lung Cancer, Advanced Non Small Cell Lung Cancer

7. Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7

   Recruiting Phase 2/3 Bristol Myers Squibb Started 2020Primary completion 2028-10 NCT04613596

   adagrasib FDA EUpembrolizumab

   Phase 2: Histologically confirmed diagnosis of unresectable or metastatic NSCLC with KRAS G12C mutation and any PD-L1 TPS

   KRAS G12CAdvanced Non-Small Cell Lung Cancer, Metastatic Non-Small Cell Lung Cancer

8. A Study of Nivolumab, Nivolumab Plus Ipilimumab, or Investigator's Choice Chemotherapy for the Treatment of Participants With Deficient Mismatch Repair (dMMR)/Microsatellite Instability High (MSI-H) Metastatic Colorectal Cancer (mCRC)

   Active, not recruiting Phase 3 Bristol Myers Squibb Started 2019Primary completion 2024-08 NCT04008030

   ipilimumab FDA EUoxaliplatinleucovorinfluorouracilirinotecanbevacizumabcetuximabnivolumab FDA EU

   Known tumor microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) status per local standard of practice

   MSI-H / dMMRMetastatic Colorectal Cancer

9. A Study to Evaluate the Safety, Tolerability, Drug Levels, and Preliminary Efficacy of BMS-986507 Combinations in Adult Participants With Advanced Solid Tumors

   Recruiting Phase 1/2 Bristol Myers Squibb Started 2025Primary completion 2031-02 NCT06618287

   izalontamab brengitecanosimertinib FDA EUpembrolizumabnivolumabpumitamig

   …ants must have pathologically confirmed locally advanced or metastatic NSCLC with an EGFR exon 19 deletion or L858R mutation in exon 21, either alone or in combination with other EGFR mutations, w…

   EGFR exon 19 deletion / L858RLung Cancer, Breast Cancer

10. A Study to Evaluate the Safety, Tolerability, and Efficacy of BMS-986523 Alone and in Combination With Anti-Cancer Agents in Participants With Advanced Solid Malignancies

    Recruiting Phase 1/2 Bristol Myers Squibb Started 2025Primary completion 2028-10 NCT07223047

    BMS-986523gemcitabinenab-paclitaxelcetuximabpembrolizumab

    …etastatic solid tumor malignancy with a known Kirsten rat sarcoma viral oncogene homolog (KRAS) alteration (mutation or amplification).

    KRAS G12CKRAS G12DAdvanced Solid Malignancies, Non-small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC), Pancreatic Ductal Adenocarcinoma (PDAC)

11. Trial of Two Adagrasib Dosing Regimens in NSCLC With KRAS G12C Mutation (KRYSTAL 21)

    Active, not recruiting Phase 2 Bristol Myers Squibb Started 2024Primary completion 2026-10 NCT05853575

    adagrasib FDA EU

    …CLC (NSCLC that started in the lungs and then spread to other parts of the body) with the KRAS G12C mutation.

    KRAS G12CAdvanced Cancer, Metastatic Cancer, Malignant Neoplasm of Lung

12. A Study to Assess the Safety, Tolerability, Efficacy, and Drug Levels of BMS-986369 (Golcadomide) in Participants With Relapsed or Refractory T-cell Lymphomas in Japan (GOLSEEK-3)

    Active, not recruiting Phase 1/2 Bristol Myers Squibb Started 2023Primary completion 2026-08 NCT06035497

    BMS-986369

    iv) Anaplastic large cell lymphoma (ALCL), anaplastic lymphoma kinase-positive (ALK+).

    ALK fusionRelapsed or Refractory T-cell Lymphomas

13. Combination Therapies With Adagrasib in Patients With Advanced NSCLC With KRAS G12C Mutation

    Active, not recruiting Phase 2 Bristol Myers Squibb Started 2022Primary completion 2026-09 NCT05609578

    adagrasib FDA EUpembrolizumabpemetrexedcisplatincarboplatin

    … unresectable or metastatic NSCLC with histologically confirmed (squamous or nonsquamous) KRASG12C mutation and histologically confirmed PD-L1 TPS ≥1%.

    KRAS G12CAdvanced NSCLC, Metastatic Lung Cancer

14. A Study of Repotrectinib in Pediatric and Young Adult Subjects Harboring ALK, ROS1, OR NTRK1-3 Alterations

    Recruiting Phase 1/2 Bristol Myers Squibb Started 2020Primary completion 2026-09 NCT04094610

    repotrectinib FDA EU

    Cohort 3: subjects with advanced solid tumors with ROS1 gene fusions or other ROS1 aberrations (including amplifications and point mutations) with measurable …

    ROS1 fusionNTRK1/2/3 fusionLocally Advanced Solid Tumors, Metastatic Solid Tumors, Lymphoma, Primary CNS Tumors

15. Phase 1/2 Study of MRTX849 in Patients With Cancer Having a KRAS G12C Mutation KRYSTAL-1

    Active, not recruiting Phase 1/2 Bristol Myers Squibb Started 2019Primary completion 2026-06 NCT03785249

    adagrasib FDA EUpembrolizumabcetuximabafatinib

    Histologically confirmed diagnosis of a solid tumor malignancy with KRAS G12C mutation

    KRAS G12CAdvanced Cancer, Metastatic Cancer, Malignant Neoplastic Disease

16. A Study of Repotrectinib (TPX-0005) in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements

    Recruiting Phase 1/2 Bristol Myers Squibb Started 2017Primary completion 2028-02 NCT03093116

    repotrectinib

    …ng primary CNS tumors) (Stage IV, American Joint Committee on Cancer v.7) that harbors an ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement by protocol specified tests.

    ALK fusionROS1 fusionNTRK1/2/3 fusionLocally Advanced Solid Tumors, Metastatic Solid Tumors

17. A Study of BMS-986488 as Monotherapy and Combination Therapy in Participants With Advanced Malignant Tumors

    Recruiting Phase 1 Bristol Myers Squibb Started 2025Primary completion 2027-10 NCT06764771

    BMS-986488adagrasib FDA EUcetuximabnivolumab

    i) Part 1B: solid tumors with KRAS G12C mutation.

    KRAS G12CAdvanced Malignant Tumors

18. Study of TPX-0022 in Patients With Advanced NSCLC, Gastric Cancer or Solid Tumors Harboring Genetic Alterations in MET

    Active, not recruiting Phase 1 Bristol Myers Squibb Started 2019Primary completion 2024-01 NCT03993873

    elzovantinib

    Histological or cytological confirmation of advanced/metastatic MET exon 14 skipping mutation (METΔex14) NSCLC, MET amplified NSCLC, or MET amplified gastric cancers…

    MET exon 14 skippingAdvanced Solid Tumor, Metastatic Solid Tumors, MET Gene Alterations

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