Opdivo

Phase 2Small molecule

Bristol-Myers Squibb

Opdivo is one of 162 small molecule programs targeting Nasopharyngeal Cancer. It is currently in Phase 2.

Indications

Total Trials

Active Trials

161

Competitors

Pipeline

Status by Indication[3][1]

Indication

Nasopharyngeal CancerRecruiting

Locally-Advanced Rectal CancerNot yet recruiting

Colorectal CancerRecruiting

MelanomaNot yet recruiting

Hepatocellular CarcinomaRecruiting

Nasopharyngeal CancerPhase 2

Recruiting

Locally-Advanced Rectal CancerPhase 1

Not yet recruiting

Colorectal CancerPhase 2

Recruiting

MelanomaPhase 1

Not yet recruiting

Hepatocellular CarcinomaPhase 1

Recruiting

Competition

Competitive Landscape

268 competitors in Colorectal Cancer

#DrugCompanyPhaseTrials

Fudr

Pfizer

Phase 3

16 2

Acetylsalicylic Acid

Bayer

Phase 3

7 3

Mfolfox6

Roche

Phase 3

5 4

Trifluridine/tipiracil

AbbVie

Phase 3

3 5

Botensilimab

AAgenus Inc.

Phase 3

10 6

XL092

Roche

Phase 3

1 7

Huaier Granule

QQidong Gaitianli Medicines Co., Ltd

Phase 3

4 8

Biological Check-up

UUniversity Hospital, Bordeaux

Phase 3

1 9

Thymosin Alpha1

SSun Yat-sen University

Phase 3

1 10

IBI363

Innovent Biologics (Suzhou) Co. Ltd.

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 1Recruiting

Hepatocellular Carcinoma

NCT07176650

Phase 3Recruiting

Esophageal Squamous Cell Carcinoma

NCT06022861

Q1 2027

Phase 1Active, not recruiting

Melanoma

NCT06112808

Phase 3Active, not recruiting

Melanoma

NCT06640530

Q2 2027

Phase 1Active, not recruiting

Follicular Lymphoma

NCT03245021

Q1 2028

Phase 1Not yet recruiting

Melanoma

NCT07476326

Clinical

Trials by Indication[1]

Melanoma3 trials

Clinical Study of the Efficacy and Safety of BCD-263 and Opdivo® as Monotherapy in Subjects With Advanced Melanoma of the Skin

Active, not recruiting·BBiocad·Phase 3·NCT06640530·392 enrolled

A Clinical Study of the Pharmacokinetics and Safety of BCD-263 and Opdivo® as Monotherapy in Subjects With Advanced Melanoma of the Skin

Active, not recruiting·BBiocad·Phase 1·NCT06112808·300 enrolled

A Randomized, Double-Blind, Parallel, Multicenter, Two-Arm Study to Compare the Pharmacokinetics, Safety, and Immunogenicity Between Bmab1700 and Opdivo® After Complete Resection of Stage IIB/C, Stage III, or Stage IV Melanoma

Not yet recruiting·BBiocon Biologics UK PLC·Phase 1·NCT07476326·120 enrolled

Hepatocellular Carcinoma2 trials

Phase I Clinical Study To Evaluate Pharmacokinetic Profile, Safety, Efficacy and Immunogenicity Of Ipilimumab Biosimilar HLX13 Vs. YERVOY® (US-Sourced YERVOY®) As A First-Line Treatment For Patients With Unresectable Hepatocellular Carcinoma

Recruiting· Shanghai Henlius Biotech logo

Shanghai Henlius Biotech·Phase 1·NCT07176650·246 enrolled

Lenvatinib Combined Anti-PD1 Antibody for the Advanced Hepatocellular Carcinoma

Completed·SSun Yat-sen University··NCT04627012·600 enrolled

Nasopharyngeal Cancer1 trial

Nivolumab in Nasopharyngeal Cancer With Progression During or After Platinum-based Treatment

Recruiting·MMaria Sklodowska-Curie National Research Institute of Oncology·Phase 2·NCT04875611·32 enrolled

Uveal Melanoma1 trial

Single Arm Trial of Tumor-Treating Fields in Combination With Nivolumab and Ipilimumab in Metastatic Uveal Melanoma

Completed·HHonorHealth Research Institute·Phase 1·NCT05004025·10 enrolled

Locally-advanced Rectal Cancer1 trial

Evaluating PD-1/PD-L1 in Locally Advanced Rectal Cancer by Quantitative Fluorescence Molecular Endoscopy

Not yet recruiting·UUniversity Medical Center Groningen·Phase 1·NCT06304597·18 enrolled

7 more indications

Follicular Lymphoma1 trial

Nivolumab Plus Rituximab in First-line Follicular Lymphoma gr 1-3A

Active, not recruiting·—·Phase 1·NCT03245021·39 enrolled

Head and Neck Squamous Cell Cancer1 trial

Safety and Efficacy of Intra-Arterial and Intra-Tumoral Ad-p53 With Capecitabine (Xeloda) or Anti-PD-1 in Liver Metastases of Solid Tumors and Recurrent Head and Neck Squamous Cell Cancer

Terminated·MMultiVir, Inc.·Phase 1/2·NCT02842125·4 enrolled

Metastatic NSCLC1 trial

Study of Carotuximab (TRC105) Plus Nivolumab in Patients With Metastatic NSCLC

Completed·TTracon Pharmaceuticals Inc.·Phase 1·NCT03181308·11 enrolled

Esophageal Squamous Cell Carcinoma1 trial

A Study to Compare the Efficacy and Safety of LY01015 and Opdivo® Combined Respectively With Chemotherapy in Advanced or Metastatic Esophageal Squamous Cell Carcinoma

Recruiting·SShandong Boan Biotechnology Co., Ltd·Phase 3·NCT06022861·510 enrolled

Adenocarcinoma1 trial

A Phase 2 Trial for Men With Metastatic Prostatic Adenocarcinoma

Completed·RRampart Health, L.L.C.·Phase 2·NCT04090775·12 enrolled

Renal Cell Carcinoma1 trial

An Investigational Immuno-Therapy Safety and Efficacy Study of Multiple Administration Regimens for Nivolumab Plus Ipilimumab in Subjects With Renal Cell Carcinoma

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT03029780·104 enrolled

Colorectal Cancer1 trial

A Randomized, Open Label, Multicenter, Phase 2 Study to Evaluate the Safety and Efficacy of Two Dose Levels of ONO-4578 With Opdivo® in Combination With mFOLFOX6 and Bevacizumab Versus Standard of Care for First-line Treatment of Non-MSI-H/dMMR, PD-L1 Positive Advanced Colorectal Cancer

Recruiting· Ono Pharmaceutical Co. Ltd logo

Ono Pharmaceutical Co. Ltd·Phase 2·NCT06948448·144 enrolled

Sources

References

[1]
ClinicalTrials.gov — 15 trial records for Opdivo. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Opdivo compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Opdivo. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Bristol-Myers Squibb company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: Bristol-Myers Squibb

Opdivo

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q2 2027

Q1 2028

Trials by Indication[1]

Melanoma3 trials

Hepatocellular Carcinoma2 trials

Nasopharyngeal Cancer1 trial

Uveal Melanoma1 trial

Locally-advanced Rectal Cancer1 trial

Follicular Lymphoma1 trial

Head and Neck Squamous Cell Cancer1 trial

Metastatic NSCLC1 trial

Esophageal Squamous Cell Carcinoma1 trial

Adenocarcinoma1 trial

Renal Cell Carcinoma1 trial

Colorectal Cancer1 trial

References

Drug Info

Quick Facts

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