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Opdivo

Phase 1

Uveal Melanoma | Small molecule | Oncology |NovoCure Limited|Last Updated: Aug 15, 2025

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment10

FDA Designations

No designations recorded

Clinical trial landscape

Opdivo · 1 trial · 1 indication

Phase 1 1
NCT05004025Single Arm Trial of Tumor-Treating Fields in Combination With Nivolumab and Ipilimumab in Metastatic Uveal MelanomaUveal Melanoma
COMPLETED10 Analytics
PHASE1COMPLETED
Single Arm Trial of Tumor-Treating Fields in Combination With Nivolumab and Ipilimumab in Metastatic Uveal Melanoma
Uveal MelanomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Overall Response Rate
from the initiation of study treatment and through study completion, up to 1 year

evaluate the overall response rate of patients with mUM treated with TTF in combination with nivolumab and ipilimumab.

Overall Safety
From the initiation of study treatment and through study completion, up to 1 year

Evaluate the safety of TTF in combination with nivolumab and ipilimumab (Number of patients who developed grade 3 treatment-related adverse events as assessed by CTCAE v5)

Secondary Endpoints

Overall Survival Rate
From initiation of study treatment until date of death from any cause, up to 100 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
TTF Plus ChemotherapyEXPERIMENTALNovacure Optune with Opdivo and Yervoy

Interventions

NameTypeDescription
Novocure OptuneDEVICENovacure Optune with Opdivo and Yervoy
OpdivoDRUGNovacure Optune with Opdivo and Yervoy
YervoyDRUGNovacure Optune with Opdivo and Yervoy
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Eligibility Criteria

Age Range18 Years to 100 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: 1. Patient has histologically or cytologically confirmed metastatic uveal melanoma with predominant liver involvement 2. Age 18 years or older and willing and able to provide informed consent 3. WOCBP must have a negative serum pregnancy test documented with 72 hours of first ad...

Countries:United States
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Frequently asked questions about Opdivo

What is Opdivo used for in uveal melanoma?

Opdivo is being studied for use in metastatic uveal melanoma. It is an investigational small molecule being evaluated in combination with nivolumab and ipilimumab. The drug is in Phase 1 clinical development for this indication, and the completed trial enrolled 10 patients in the United States.

What does Opdivo target?

Opdivo targets the PD-1 receptor, a protein on immune cells that helps regulate immune responses. By blocking PD-1, Opdivo is designed to enhance the immune system's ability to fight cancer cells. In the context of uveal melanoma, it is being tested in combination with other agents to potentially improve treatment outcomes.

Who makes Opdivo?

Opdivo is being developed by NovoCure Limited, a company traded on the NASDAQ under the ticker symbol NVCR. The company is conducting clinical research on Opdivo for the treatment of metastatic uveal melanoma, with the drug currently in Phase 1 development.

What phase is Opdivo in?

Opdivo is in Phase 1 clinical development for metastatic uveal melanoma. It is an investigational drug, meaning it has not been approved by regulatory authorities. The completed Phase 1 trial, NCT05004025, evaluated the drug in combination with nivolumab and ipilimumab in 10 patients.

What clinical trials is Opdivo in?

Opdivo has one completed clinical trial, NCT05004025, titled "Single Arm Trial of Tumor-Treating Fields in Combination With Nivolumab and Ipilimumab in Metastatic Uveal Melanoma." This Phase 1 trial enrolled 10 patients in the United States and was not randomized or double-blinded, and it did not use a control group.

Is Opdivo the same as nivolumab?

Opdivo is the brand name for nivolumab, a PD-1 inhibitor. In the clinical trial for uveal melanoma, Opdivo (nivolumab) is being tested in combination with ipilimumab, another immunotherapy drug. The trial combines these agents to evaluate their safety and efficacy in metastatic uveal melanoma.