Recent Updates
Recently added Catalysts

Bexmarilimab/kg and nivolumab/kg

Phase 1

Melanoma (Skin Cancer) | Small molecule | Oncology |United Therapeutics Corporation|Last Updated: Jul 21, 2026

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment62

FDA Designations

No designations recorded

Clinical trial landscape

Bexmarilimab/kg and nivolumab/kg · 1 trial · 3 indications

Phase 1 1
NCT07718243Investigating the Combination of Bexmarilimab and Nivolumab in Solid Tumours, Melanoma and NSCLCMelanoma (Skin Cancer)
NOT YET_RECRUITING62 Analytics
PHASE1NOT YET_RECRUITING
Investigating the Combination of Bexmarilimab and Nivolumab in Solid Tumours, Melanoma and NSCLC
Melanoma (Skin Cancer)
NCT0771824362
Unlock trial analytics

Study Endpoints

Primary Endpoints

To establish a recommended Phase II dose (RP2D) of bexmarilimab in combination with nivolumab
At the end of Cycle 2 (Cycle 1 is 28 days and Cycle 2 is 21 days)".
Determining causality of each adverse event to bexmarilimab and nivolumab and grading severity according to the NCI CTCAE Version 5.0
From the start of treatment until the end of the trial (due to documented disease progression or withdrawal of consent or toxicity), with follow-up continuing for 28 days after the last dose of the IMP.
Evaluation of disease response by RECIST criteria version 1.1, immune-modified RECIST (iRECIST) and thus overall response rate
From date of enrolment until the date of first documented progression, assessed up to 48 months

Secondary Endpoints

Evaluation of disease response by RECIST criteria version 1.1, iRECIST and thus response rate, clinical benefit rate, radiological PFS and overall survival.
From date of enrolment until the date of first documented progression, assessed up to 48 months
Determination of changes in markers of target inhibition and immune microenvironment in tumour and blood.
48 months
Unlock Study Endpoints

Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Phase I: Dose EscalationEXPERIMENTALPhase I will establish a recommended Phase 2 dose (RP2D) of Bexmarilimab in combination with Nivolumab
Phase II: Dose ExpansionEXPERIMENTALPhase II will assess the anti-tumour activity of bexmarilimab in combination with nivolumab

Interventions

NameTypeDescription
Bexmarilimab 1mg/kg and nivolumab 1mg/kgDRUGDose Level 1
Bexmarilimab 3mg/kg and nivolumab 1mg/kgDRUGDose Level 2
Recommended Phase II DoseDRUGRecommended Phase II Dose of bexmarilimab in combination with nivolumab established from Dose Escalation
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: 1. Part A: Histologically proven solid tumour, refractory to conventional treatment, or for which no conventional therapy exists or is declined by the patient Part B1: Histologically proven NSCLC. * Patient has received at least one but not more than three lines of sy...

Countries:United Kingdom
Unlock Eligibility Criteria

Frequently asked questions about Bexmarilimab/kg and nivolumab/kg

What is Bexmarilimab/kg and nivolumab/kg used for?

Bexmarilimab/kg and nivolumab/kg is an investigational combination therapy being studied for the treatment of melanoma (skin cancer), as well as non-small cell lung cancer and advanced solid tumors. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes Bexmarilimab/kg and nivolumab/kg?

Bexmarilimab/kg and nivolumab/kg is being developed by United Therapeutics Corporation, which trades under the ticker symbol UTHR. The company is conducting clinical trials to evaluate this combination therapy in oncology indications.

What phase is Bexmarilimab/kg and nivolumab/kg in?

Bexmarilimab/kg and nivolumab/kg is in Phase 1 clinical development. It is an investigational therapy, meaning it has not yet received regulatory approval and is still being evaluated in clinical trials for safety and efficacy.

What clinical trials is Bexmarilimab/kg and nivolumab/kg in?

Bexmarilimab/kg and nivolumab/kg is being studied in a Phase 1 clinical trial with the identifier NCT07718243. This trial is investigating the combination of bexmarilimab and nivolumab in solid tumors, melanoma, and non-small cell lung cancer, with an enrollment of 62 participants.

Is Bexmarilimab/kg and nivolumab/kg the same as Bexmarilimab 1mg/kg and nivolumab 1mg/kg?

Yes, Bexmarilimab/kg and nivolumab/kg is also known as Bexmarilimab 1mg/kg and nivolumab 1mg/kg. These names refer to the same investigational combination therapy being developed by United Therapeutics Corporation.