Recent Updates
Recently added Catalysts

Opdivo

Phase 1

Follicular Lymphoma | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Jul 30, 2024

Target and mechanism

Molecular targetPDCD1
Target classInhibitor
ModalitySmall molecule

Also known as Nivolumab, Nivolumab Injection [Opdivo], nivolumab, Neoadjuvant nivolumab, Nivolumab and rHuPH20, nivolumab 480mg, Nivolumab 480mg and relatlimab 160mg, Nivolumab and relatlimab

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment39

FDA Designations

BREAKTHROUGH_THERAPYPRIORITY_REVIEW

Clinical trial landscape

Opdivo · 1 trial · 1 indication

Phase 1 1
NCT03245021Nivolumab Plus Rituximab in First-line Follicular Lymphoma gr 1-3AFollicular Lymphoma
ACTIVE NOT_RECRUITING39 Analytics
PHASE1ACTIVE NOT_RECRUITING
Nivolumab Plus Rituximab in First-line Follicular Lymphoma gr 1-3A
Follicular LymphomaUnlock trial analytics

Study Endpoints

Primary Endpoints

To evaluate the feasibility and safety of combination nivolumab and rituximab as determined by the proportion of toxicity grade 3 or higher per CTCAE v4.0 occurring on induction treatment (ie first 16 weeks of therapy)
1st 16 weeks of therapy

As determined by rate of toxicity grade 3 or higher per CTCAE v4.0

Secondary Endpoints

Overall toxicity
5 years
Response rate
1st 16 weeks of therapy
Complete response rate
6 months post completion of induction treatment
Unlock Study Endpoints

Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Open-LabelOTHEROpdivo - Single-arm open label study

Interventions

NameTypeDescription
OpdivoDRUGAll patients will receive: Nivolumab 240mg IV q2-weekly for four cycles Patients in complete remission (CR): Nivolumab 240mg IV q2-weekly for four further cycles (8 in total) Patients with partial response (PR), stable disease (SD), asymptomatic or minor progressive disease (PD) post 4cycles receive: Nivolumab 240mg IV plus rituximab 375mg/m2 IV q2-weekly for four cycles Patients in CR: Nivolumab 240mg IV q2-weekly for four further cycles (8 in total) Patients with PR, SD, asymptomatic or minor PD post 4 cycles receive: Nivolumab 240mg IV plus rituximab 375mg/m2 IV q2-weekly for four cycles
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: 1. Age ≥ 18 years. 2. Histologically proven Follicular non Hodgkin lymphoma (FL) grades 1-3A according to the current World Health Organization classification.29 The B cell nature of the proliferation must be verified by the positivity with an anti-CD20 antibody. 3. No previous ...

Countries:Australia
Unlock Eligibility Criteria

Frequently asked questions about Opdivo

What is BMS-936558 used for?

BMS-936558, also known as nivolumab and marketed as Opdivo, is an investigational oncology drug being studied for advanced or metastatic melanoma, non-squamous cell non-small cell lung cancer, localized oesogastric adenocarcinoma, follicular lymphoma, cancer, and gastric cancer. It is developed by Bristol-Myers Squibb Company (BMY) and is currently in Phase 1 clinical development.

What does BMS-936558 target?

BMS-936558 is a monoclonal antibody (target class -mab) that targets the programmed cell death protein 1 (PD-1) receptor. By binding to PD-1, it is designed to enhance the immune system's ability to fight cancer cells. This mechanism is being evaluated across multiple oncology indications.

Who makes BMS-936558?

BMS-936558 is developed by Bristol-Myers Squibb Company, a biopharmaceutical company traded on the New York Stock Exchange under the ticker BMY. The drug is also known as nivolumab and is marketed under the brand name Opdivo.

What phase is BMS-936558 in?

BMS-936558 is currently in Phase 1 clinical development. It has received FDA breakthrough therapy designation and priority review status. The drug is investigational and not yet approved, with ongoing clinical trials evaluating its safety and efficacy in various cancer types.

What clinical trials is BMS-936558 in?

BMS-936558 has been studied in multiple clinical trials, including NCT02741570, a Phase 3 trial in head and neck cancer, and NCT02823574, a Phase 2 trial in the same condition. Other trials include NCT03355560 and NCT03894891, both Phase 2 studies in head and neck cancer. Across 14 trials, total enrollment is 6,828 patients.

Is BMS-936558 the same as Opdivo?

Yes, BMS-936558 is the same as Opdivo. The drug is also known as nivolumab, nivolumab injection, and nivolumab 10 mg/ml. It is being developed by Bristol-Myers Squibb and is currently in Phase 1 trials for multiple oncology indications.