Opdivo

Phase 2Small molecule

Bristol-Myers Squibb

Opdivo is one of 155 small molecule programs targeting Colorectal Cancer. It is currently in Phase 2.

Indications

Total Trials

Active Trials

154

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Colorectal CancerRecruiting

MelanomaRecruiting

Hepatocellular CarcinomaRecruiting

Locally-Advanced Rectal CancerNot yet recruiting

Nasopharyngeal CancerRecruiting

Colorectal CancerPhase 2

Recruiting

MelanomaPhase 1

Recruiting

Hepatocellular CarcinomaPhase 1

Recruiting

Locally-Advanced Rectal CancerPhase 1

Not yet recruiting

Nasopharyngeal CancerPhase 2

Recruiting

Competition

Competitive Landscape

254 competitors in Colorectal Cancer

#DrugCompanyPhaseTrials

Camptosar

Pfizer

Phase 3

34 2

Platinol

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Phase 3

4 3

5-Fu

TToray Industries, Inc

Phase 3

4 4

Cadonilimab

SShanghai Pharmaceuticals Holding Co., Ltd

Phase 3

2 5

Cytokine-Induced Killer Cells

TThe First People's Hospital of Changzhou

Phase 3

2 6

BL-M07D1

SSichuan Baili Pharmaceutical Co., Ltd.

Phase 3

1 7

Opdivo

Bristol-Myers Squibb

Phase 2

1 8

Calcium Levofolinate

FFujian Cancer Hospital

Phase 3

1 9

Mfolfoxiri Plus Bevacizumab

FFudan University

Phase 3

1 10

Leucovorin and 5-FU

AAkeso

Phase 3

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

Timeline

Expected Milestones

Q4 2026

Phase 1Recruiting

Hepatocellular Carcinoma

NCT07176650

Q1 2027

Phase 1Active, not recruiting

Melanoma

NCT06112808

Phase 3Active, not recruiting

Melanoma

NCT06640530

Q2 2027

Phase 1Active, not recruiting

Follicular Lymphoma

NCT03245021

Q4 2027

Phase 2Recruiting

Nasopharyngeal Cancer

NCT04875611

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

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

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

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

7 more indications

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

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

Follicular Lymphoma1 trial

First-line Treatment for Grade 1-3A Follicular Lymphoma Using Opdivo (Nivolumab) Plus Rituximab: The 1st FLOR Study

Active, not recruiting·DDr. Eliza Hawkes·Phase 1·NCT03245021·39 enrolled

Nasopharyngeal Cancer1 trial

Phase II Study Evaluating the Efficacy of Nivolumab in the Treatment of Patients With Nasopharyngeal Cancer Who Progressed During or After Platinum-based Chemotherapy

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

Esophageal Squamous Cell Carcinoma1 trial

A Randomized, Double-blind, Multicenter, Phase 3 Study to Compare the Efficacy and Safety of LY01015 and Opdivo®（Nivolumab Injection）Combined Respectively With Fluorouracil Plus Cisplatin in Participants With Advanced or Metastatic Esophageal Squamous Cell Carcinoma.

Active, not recruiting·SShandong Boan Biotechnology Co., Ltd·Phase 3·NCT06022861·510 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

Regulatory

FDA Approval Timeline[4]

Apr 14, 2015

OPDIVO

NDA BLA125554

Apr 14, 2015

OPDIVO

NDA BLA125554

Sep 30, 2015

OPDIVO

NDA BLA125554

Oct 9, 2015

OPDIVO

NDA BLA125554

Nov 23, 2015

OPDIVO

NDA BLA125554

Nov 23, 2015

OPDIVO

NDA BLA125554

Jan 23, 2016

OPDIVO

NDA BLA125554

May 17, 2016

OPDIVO

NDA BLA125554

Sep 13, 2016

OPDIVO

NDA BLA125554

Sep 13, 2016

OPDIVO

NDA BLA125554

Oct 4, 2016

OPDIVO

NDA BLA125554

Nov 10, 2016

OPDIVO

NDA BLA125554

Feb 2, 2017

OPDIVO

NDA BLA125554

Apr 25, 2017

OPDIVO

NDA BLA125554

Jul 31, 2017

OPDIVO

NDA BLA125554

Sep 6, 2017

OPDIVO

NDA BLA125554

Sep 22, 2017

OPDIVO

NDA BLA125554

Dec 20, 2017

OPDIVO

NDA BLA125554

Jan 9, 2018

OPDIVO

NDA BLA125554

Jan 9, 2018

OPDIVO

NDA BLA125554

Jan 9, 2018

OPDIVO

NDA BLA125554

Jan 9, 2018

OPDIVO

NDA BLA125554

Jan 9, 2018

OPDIVO

NDA BLA125554

Feb 13, 2018

OPDIVO

NDA BLA125554

Feb 15, 2018

OPDIVO

NDA BLA125554

Feb 15, 2018

OPDIVO

NDA BLA125554

Mar 5, 2018

OPDIVO

NDA BLA125554

Mar 5, 2018

OPDIVO

NDA BLA125554

Mar 5, 2018

OPDIVO

NDA BLA125554

Mar 5, 2018

OPDIVO

NDA BLA125554

Mar 5, 2018

OPDIVO

NDA BLA125554

Mar 5, 2018

OPDIVO

NDA BLA125554

Mar 5, 2018

OPDIVO

NDA BLA125554

Mar 5, 2018

OPDIVO

NDA BLA125554

Mar 5, 2018

OPDIVO

NDA BLA125554

Mar 5, 2018

OPDIVO

NDA BLA125554

Apr 16, 2018

OPDIVO

NDA BLA125554

Jul 10, 2018

OPDIVO

NDA BLA125554

Aug 16, 2018

OPDIVO

NDA BLA125554

Nov 15, 2018

OPDIVO

NDA BLA125554

Feb 1, 2019

OPDIVO

NDA BLA125554

Mar 7, 2019

OPDIVO

NDA BLA125554

Apr 18, 2019

OPDIVO

NDA BLA125554

May 2, 2019

OPDIVO

NDA BLA125554

Sep 18, 2019

OPDIVO

NDA BLA125554

Mar 10, 2020

OPDIVO

NDA BLA125554

May 15, 2020

OPDIVO

NDA BLA125554

May 26, 2020

OPDIVO

NDA BLA125554

Jun 10, 2020

OPDIVO

NDA BLA125554

Jun 23, 2020

OPDIVO

NDA BLA125554

Sep 18, 2020

OPDIVO

NDA BLA125554

Sep 18, 2020

OPDIVO

NDA BLA125554

Sep 25, 2020

OPDIVO

NDA BLA125554

Oct 2, 2020

OPDIVO

NDA BLA125554

Nov 10, 2020

OPDIVO

NDA BLA125554

Dec 29, 2020

OPDIVO

NDA BLA125554

Jan 22, 2021

OPDIVO

NDA BLA125554

Mar 30, 2021

OPDIVO

NDA BLA125554

Apr 16, 2021

OPDIVO

NDA BLA125554

May 20, 2021

OPDIVO

NDA BLA125554

Jul 15, 2021

OPDIVO

NDA BLA125554

Jul 23, 2021

OPDIVO

NDA BLA125554

Aug 19, 2021

OPDIVO

NDA BLA125554

Feb 25, 2022

OPDIVO

NDA BLA125554

Mar 4, 2022

OPDIVO

NDA BLA125554

May 11, 2022

OPDIVO

NDA BLA125554

May 27, 2022

OPDIVO

NDA BLA125554

May 27, 2022

OPDIVO

NDA BLA125554

Jul 14, 2022

OPDIVO

NDA BLA125554

Feb 15, 2023

OPDIVO

NDA BLA125554

Feb 15, 2023

OPDIVO

NDA BLA125554

Feb 15, 2023

OPDIVO

NDA BLA125554

Oct 13, 2023

OPDIVO

NDA BLA125554

Jan 26, 2024

OPDIVO

NDA BLA125554

Mar 6, 2024

OPDIVO

NDA BLA125554

Mar 6, 2024

OPDIVO

NDA BLA125554

Oct 3, 2024

OPDIVO

NDA BLA125554

Dec 27, 2024

OPDIVO QVANTIG

NDA BLA761381

Apr 8, 2025

OPDIVO

NDA BLA125554

Apr 11, 2025

OPDIVO

NDA BLA125554

May 23, 2025

OPDIVO QVANTIG

NDA BLA761381

May 23, 2025

OPDIVO

NDA BLA125554

Jul 1, 2025

OPDIVO

NDA BLA125554

Oct 27, 2025

OPDIVO QVANTIG

NDA BLA761381

Nov 24, 2025

OPDIVO QVANTIG

NDA BLA761381

Mar 20, 2026

OPDIVO

NDA BLA125554

May 12, 2026

OPDIVO QVANTIG

NDA BLA761381

May 12, 2026

OPDIVO

NDA BLA125554

Aug 12, 2026

OPDIVO

NDA BLA125554

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]
OpenFDA — FDA approval records (NDA BLA125554). U.S. Food & Drug Administration.
[5]
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

Q4 2027

Trials by Indication[1]

Melanoma3 trials

Hepatocellular Carcinoma2 trials

Uveal Melanoma1 trial

Head and Neck Squamous Cell Cancer1 trial

Metastatic NSCLC1 trial

Adenocarcinoma1 trial

Renal Cell Carcinoma1 trial

Locally-advanced Rectal Cancer1 trial

Follicular Lymphoma1 trial

Nasopharyngeal Cancer1 trial

Esophageal Squamous Cell Carcinoma1 trial

Colorectal Cancer1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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