MelanomaPhase 1/2NCT04370704

Study of Combination Therapy With INCMGA00012 (Anti-PD-1), INCAGN02385 (Anti-LAG-3), and INCAGN02390 (Anti-TIM-3) in Participants With Select Advanced Malignancies

A Phase 1/2 study testing INCAGN02385, INCAGN02390 and INCMGA00012. in people with Melanoma, run by Incyte Corporation at 17 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The study will determine Recommended Phase 2 Dose for all study drugs, based on the safety and tolerability of the following combinations: INCAGN02385 + INCAGN02390 and INCAGN02385 + INCAGN02390 + INCMGA00012. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Melanoma
What is being tested?: INCAGN02385, INCAGN02390 and INCMGA00012.
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 61 participants
Where: 17 sitesin 2 countries
Study dates: 27 Jul 2020to 25 Aug 2025
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Phase 1 Parts 1-4): Participants with locally advanced or metastatic solid tumors (locally advanced disease must not be amenable to resection with curative intent) that have failed available therapies, including anti-PD-(L)1 therapy if applicable, that are known to confer clinical benefit, or who are intolerant to, or ineligible for standard treatment. Prior anti-PD-(L)1 therapy should not have been discontinued because of intolerance.
Phase 2, Cohort A:
Participant with histologically confirmed unresectable/metastatic melanoma, whose disease failed prior anti-PD-(L)1 therapy (alone or as part of a combination) and meeting one of the following criteria:
Participant who failed prior adjuvant anti-PD-(L)1 therapy for resectable melanoma must have received prior anti-PD-(L)1 for ≥ 6 weeks and experienced disease progression while still on active adjuvant therapy containing anti-PD-(L)1, or participant who had early relapse occurring < 24 weeks after end of adjuvant anti-PD-(L)1 therapy. Progressive disease must be ascertained by confirmatory biopsy collected at baseline.
Participant whose unresectable/metastatic disease progressed while on or within < 24 weeks of completion of anti-PD-(L)1 for inresectable/metastatic melanoma. Progressive disease must have been confirmed by imaging ≥ 4 weeks after evidence of initial disease progression.
Participant must have received no more than 2 prior lines of therapy for melanoma and at least one prior regimen must have contained anti-PD-(L)1 therapy (alone or as part of a combination) either in the adjuvant and/or advanced/metastatic setting.

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Participants must have had known BRAF V600 mutation status per local institutional testing standards.
Participants must have fresh biopsy available after completing prior PD-(L)1 therapy or be willing and able to safely undergo pretreatment tumor biopsies (core or excisional). Determination of whether participants can safely undergo biopsy should be made by the treating physician in consultation with the individual performing the biopsy.
Participant must have at least 1 measurable tumor lesion per RECIST v1.1.
Phase 2, Cohort B:
Participant with previously untreated, histologically confirmed Stage III (unresectable) or IV melanoma per the American Joint Committee on Cancer v8 staging system.
Participants must not have had prior systemic anticancer therapy for unresectable or metastatic melanoma.
Participants must have had known BRAF V600 mutation status per local institutional testing standards.
Participants must have fresh biopsy available or be willing and able to safely undergo pretreatment tumor biopsies (core or excisional). Determination of whether participants can safely undergo biopsy should be made by the treating physician in consultation with the individual performing the biopsy.
Phase 2 (Cohorts A and B): Participant must have at least 1 measurable tumor lesion per RECIST v1.1.
ECOG performance status 0 or 1.
Willingness to avoid pregnancy or fathering children

Who cannot join

Laboratory and medical history parameters outside the protocol-defined range.
Known hypersensitivity or severe reaction to any component of the study drugs or formulation components ) within 14 days before study Day 1.
Participant who had prior treatment with a LAG-3 or TIM-3 targeted agent.
Phase 1: (Parts 1-4):
Receipt of anticancer medications or investigational drugs within the following intervals before the first administration of study treatment:
≤28 days or 5 half-lives (whichever is longer) before the first dose for all other investigational agents or devices. For investigational agents with long half-lives (eg, > 5 days), enrollment before the fifth half-life requires medical monitor approval.

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Administration of colony-stimulating factors (including granulocyte colony-stimulating factor, granulocyte macrophage colony-stimulating factor, or recombinant erythropoietin) within 14 days before study Day 1.
Phase 2:
Cohort A: Participant who has discontinued anti-PD-(L)1 therapy due to toxicity or other reasons unrelated to toxicity, then subsequently experienced disease progression.
Cohort A: Participant who had experienced objective response (PR/CR) and had stopped anti-PD-(L)1 therapy due to maximal benefit.
Cohort A: Participant with multiple metastases that achieved mixed tumor response to prior anti-PD-(L)1 therapy (such as isolated progressive lesion in a context of PR/CR or SD for other lesions) or achieved overall disease progression based only on a single new lesion.
Cohort B: Participant who has or has had uveal melanoma.
Receipt of anticancer therapy (immunotherapy, chemotherapy, targeted therapy or hormonal therapy) within 21 days of the first administration of study treatment, with the exception of localized radiotherapy.
Palliative radiation therapy administered within 1 week of first dose of study treatment or radiation therapy in the thoracic region that is > 30 Gy within 6 months of the first dose of study treatment.
If participant received major surgery, then they must have recovered adequately from toxicities and/or complications from the intervention before starting study treatment.
Treatment-related toxicity related to prior therapy that has not recovered to ≤ Grade 1 (with the exception of alopecia and anemia not requiring transfusional support), unless approved by the medical monitor.
History of immune-related toxicity during prior checkpoint inhibitor therapy for which permanent discontinuation of therapy is recommended (per product label or consensus guidelines), OR any immune-related toxicity requiring intensive or prolonged immunosuppression to manage (with the exception of endocrinopathy that is well controlled on stable dose of replacement hormones such as hypothyroidism or adrenal insufficiency, or Grade 3 rashes that resolved with topical therapy or asymptomatic lipase elevations that do not require treatment interruption or uveitis that resolved with steroid drops).
Has an active autoimmune disease requiring systemic immunosuppression with corticosteroids (> 10 mg/day of prednisone or equivalent) or immunosuppressive drugs within 14 days before the first dose of study treatment.
Receiving chronic systemic corticosteroids (> 10 mg/day of prednisone or equivalent).
Active infections requiring systemic antibiotics, or antifungal or antiviral treatment within 7 days before first dose of study treatment.
History of organ transplant, including allogeneic stem cell transplantation.
Evidence of interstitial lung disease or active, noninfectious pneumonitis.
Known active HBV or HCV infection or risk of reactivation of HBV or HCV.
Participants who are known to be HIV-positive .
Known active brain or CNS metastases including carcinomatous meningitis.
Known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 2 years of study entry with the exception of cured basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy after treatment with curative intent.
Participants with impaired cardiac function or clinically significant cardiac disease
History or presence of an abnormal ECG that, in the investigator's opinion, is clinically meaningful.
Women who are pregnant or breastfeeding.
Receipt of a live vaccine within 30 days of planned start of study treatment.

Trial locations and contacts

17 sites in 2 countries.

Country

City, postcode or hospital

17 sites in 2 countries

United States12 sites

Cancer Center For Blood Disorders A Division of American Oncology Partners P.A
Bethesda, Maryland, 20817
John Theurer Cancer Center, Hackensack University Medical Center
Hackensack, New Jersey, 07601
Penn State Hershey Cancer Institute
Hershey, Pennsylvania, 17033
Carolina Bio Oncology
Huntersville, North Carolina, 28078
University of Iowa
Iowa City, Iowa, 52242
The Angeles Clinic and Research Institute
Los Angeles, California, 90025
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
Nyu Langone Laura and Isaac Perlmutter Cancer Center
New York, New York, 10016
Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
University of Washington-Seattle Cancer Care Alliance
Seattle, Washington, 98109
Washington University
St Louis, Missouri, 63110
H Lee Moffitt Cancer Center and Research
Tampa, Florida, 33612

Other trials in United States

Australia5 sites

Flinders Medical Centre
Bedford Park, South Australia, 05042
Box Hill Hospital
Box Hill, Victoria, 03128
Greenslopes Private Hospital
Brisbane, Queensland
One Clinical Research
Nedlands, Western Australia, 06009
Melanoma Institute Australia
Wollstonecraft, New South Wales, 02060

Other trials in Australia

About this study

Official title: A Phase 1-2 Study of Combination Therapy With INCMGA00012 (Anti-PD-1), INCAGN02385 (Anti-LAG-3), and INCAGN02390 (Anti-TIM-3) in Participants With Select Advanced Malignancies

Conditions: Melanoma
Being tested: INCAGN02385, INCAGN02390, INCMGA00012.
Keywords: PD-1 Inhibitors, INCAGN02385, INCAGN02390, INCMGA00012, Retifanlimab
Medical subject headings: Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

INCAGN02385Drug
INCAGN02385 administered intravenously
INCAGN02390Drug
INCAGN02390 administered intravenously
INCMGA00012.Drug
INCMGA00012 administered intravenously

Study groups in NCT04370704
Study group	Role	What they receive
Phase 1 Part 1	Experimental	Part 1 will confirm the safety of INCAGN02385 and INCAGN02390 when used in combination. INCAGN02385 will be administered first intravenously followed by INCAGN02390. Receives: Drug: INCAGN02385; Drug: INCAGN02390
Phase 1 Part 2	Experimental	Part 2 will confirm the safety of the triple combination of INCAGN02385 + INCAGN02390 + INCMGA00012, following confirmation of the safety of the doublet in Part 1. INCAGN02385 will be administered first intravenously followed by INCAGN02390 and INCMGA00012. Receives: Drug: INCAGN02385; Drug: INCAGN02390; Drug: INCMGA00012.
Phase 2 Cohort A	Experimental	Phase 2 will determine preliminary efficacy and proof of concept for the combination of INCAGN02385 + INCAGN02390 + INCMGA00012. INCAGN02385 will be administered first intravenously followed by INCAGN02390 and INCMGA00012 Receives: Drug: INCAGN02385; Drug: INCAGN02390; Drug: INCMGA00012.
Phase 2 Cohort B	Experimental	Phase 2 will determine preliminary efficacy and proof of concept for the combination of INCAGN02385 + INCAGN02390 + INCMGA00012. INCAGN02385 will be administered first intravenously followed by INCAGN02390 and INCMGA00012 Receives: Drug: INCAGN02385; Drug: INCAGN02390; Drug: INCMGA00012.
Phase 1 Part 3	Experimental	Part 1 will confirm the safety of INCAGN02385 + INCAGN02390 + INCMGA00012 when used in combination. Receives: Drug: INCAGN02385; Drug: INCAGN02390; Drug: INCMGA00012.
Phase 1 Part 4	Experimental	Part 1 will confirm the safety of INCAGN02385 + INCAGN02390 + INCMGA00012 in combination. Receives: Drug: INCAGN02385; Drug: INCAGN02390; Drug: INCMGA00012.

What is being measured

The primary outcome is the main question the study is designed to answer.

Phase 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as an AE either reported for the first time or the worsening of a pre-existing event, after the first dose of study drug until 90 days after the last dose of study drug.
Measured: up to 1148 days
Phase 1: Number of Participants With Any ≥Grade 3 TEAE
The severity of AEs was assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grades 1 through 5. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal. An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A TEAE was defined as an AE reported either reported for the first time or the worsening of a pre-existing event, after the first dose of study drug until 90 days after the last dose of study drug.
Measured: up to 1148 days

Secondary outcomes (10)

Phase 2: Objective Response Rate (ORR)
ORR was defined as the percentage of participants with a complete response (CR) or partial response (PR), as determined by investigator assessment of radiographic disease assessments per Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 (v1.1).
Measured: up to 325 days
Phase 2: Duration of Response (DOR)
DOR was defined as the time from the earliest date of disease response (CR or PR) until the earliest date of disease progression, as determined by investigator assessment of radiographic disease per RECIST v1.1, or death from any cause, if it occurred sooner than progression.
Measured: up to 325 days
Phase 2: Disease Control Rate (DCR)
DCR was defined as the percentage of participants with CR, PR, or stable disease (SD) as best on-study response on or after Day 56.
Measured: up to 325 days beyond Day 56
Phase 2: Progression-free Survival (PFS)
PFS was defined as the time from the date of the first dose of study treatment until the earliest date of disease progression, as determined by investigator assessment of objective radiographic disease per RECIST v1.1, or death due to any cause.
Measured: up to 325 days
Phase 2: Number of Participants With Any TEAE
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as an AE either reported for the first time or the worsening of a pre-existing event, after the first dose of study drug until 90 days after the last dose of study drug.
Measured: up to 415 days
Phase 2: Number of Participants With Any ≥Grade 3 TEAE
The severity of AEs was assessed using CTCAE version 5.0 Grades 1 through 5. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal. An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A TEAE was defined as an AE reported for the first time or the worsening of a pre-existing event after the first dose of study treatment.
Measured: up to 415 days
Phase 1: ORR
ORR was defined as the percentage of participants with a CR or PR, as determined by investigator assessment of radiographic disease assessments per RECIST v1.1.
Measured: up to 1058 days
Phase 1: DOR
DOR was defined as the time from the earliest date of disease response (CR or PR) until the earliest date of disease progression, as determined by investigator assessment of radiographic disease per RECIST v1.1, or death from any cause, if it occurred sooner than progression.
Measured: up to 1058 days
Phase 1: DCR
DCR was defined as the percentage of participants with CR, PR, or SD as best on study response and or after Day 56.
Measured: up to 1058 days beyond Day 56
Phase 1: PFS
PFS was defined as the time from the date of the first dose of study treatment until the earliest date of disease progression, as determined by investigator assessment of objective radiographic disease per RECIST v1.1, or death due to any cause.
Measured: up to 1058 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Jul 202025 Aug 2025

First posted1 May 2020
Study start27 Jul 2020
Primary completion25 Aug 2025
Study completion25 Aug 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for MelanomaStudies of the same condition, open and under way.
More trials run by Incyte CorporationThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 61 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04370704
Sponsor's protocol ID: INCAGN 2385-201
Other IDs: 2021-005775-39
Status last verified: Aug 2026
First submitted: 29 Apr 2020
Last updated: 17 Aug 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
Expanded access: Available

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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IL-17 Blockade to Decrease irAEs (REPLAY)
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Enrolling by invitationObservational study
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Prostate Cancer, Leukemia
RecruitingPhase 1
A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy
Melanoma
Active, not recruitingPhase 1/2
A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma
Melanoma

All Melanoma trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1-2 Study of Combination Therapy With INCMGA00012 (Anti-PD-1), INCAGN02385 (Anti-LAG-3), and INCAGN02390 (Anti-TIM-3) in Participants With Select Advanced Malignancies
ClinicalTrials.gov ID: NCT04370704
Acronym / sponsor ID: INCAGN 2385-201
Conditions: Melanoma
Keywords: PD-1 Inhibitors, INCAGN02385, INCAGN02390, INCMGA00012, Retifanlimab
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 61 participants (actual)
Lead sponsor: Incyte CorporationIndustry (pharma, biotech, devices)
Study start: 27 Jul 2020 (actual)
Primary completion: 25 Aug 2025 (actual)
Study completion: 25 Aug 2025 (actual)
First posted: 1 May 2020 (actual)
Results: Posted 17 Aug 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Phase 1 Part 1	Experimental	Drug: INCAGN02385, Drug: INCAGN02390Part 1 will confirm the safety of INCAGN02385 and INCAGN02390 when used in combination. INCAGN02385 will be administered first intravenously followed by INCAGN02390.
Phase 1 Part 2	Experimental	Drug: INCAGN02385, Drug: INCAGN02390, Drug: INCMGA00012.Part 2 will confirm the safety of the triple combination of INCAGN02385 + INCAGN02390 + INCMGA00012, following confirmation of the safety of the doublet in Part 1. INCAGN02385 will be administered first intravenously followed by INCAGN02390 and INCMGA00012.
Phase 2 Cohort A	Experimental	Drug: INCAGN02385, Drug: INCAGN02390, Drug: INCMGA00012.Phase 2 will determine preliminary efficacy and proof of concept for the combination of INCAGN02385 + INCAGN02390 + INCMGA00012. INCAGN02385 will be administered first intravenously followed by INCAGN02390 and INCMGA00012
Phase 2 Cohort B	Experimental	Drug: INCAGN02385, Drug: INCAGN02390, Drug: INCMGA00012.Phase 2 will determine preliminary efficacy and proof of concept for the combination of INCAGN02385 + INCAGN02390 + INCMGA00012. INCAGN02385 will be administered first intravenously followed by INCAGN02390 and INCMGA00012
Phase 1 Part 3	Experimental	Drug: INCAGN02385, Drug: INCAGN02390, Drug: INCMGA00012.Part 1 will confirm the safety of INCAGN02385 + INCAGN02390 + INCMGA00012 when used in combination.
Phase 1 Part 4	Experimental	Drug: INCAGN02385, Drug: INCAGN02390, Drug: INCMGA00012.Part 1 will confirm the safety of INCAGN02385 + INCAGN02390 + INCMGA00012 in combination.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (17 listed)

Phase 1 Parts 1-4): Participants with locally advanced or metastatic solid tumors (locally advanced disease must not be amenable to resection with curative intent) that have failed available therapies, including anti-PD-(L)1 therapy if applicable, that are known to confer clinical benefit, or who are intolerant to, or ineligible for standard treatment. Prior anti-PD-(L)1 therapy should not have been discontinued because of intolerance.
Phase 2, Cohort A:
Phase 2, Cohort B:
Phase 2 (Cohorts A and B): Participant must have at least 1 measurable tumor lesion per RECIST v1.1.
ECOG performance status 0 or 1.

Key exclusion criteria (30 listed)

Laboratory and medical history parameters outside the protocol-defined range.
Known hypersensitivity or severe reaction to any component of the study drugs or formulation components ) within 14 days before study Day 1.
Participant who had prior treatment with a LAG-3 or TIM-3 targeted agent.
Receipt of anticancer medications or investigational drugs within the following intervals before the first administration of study treatment:
Phase 2:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
INCAGN02385INCAGN02385 administered intravenously	Drug	Phase 1 Part 1, Phase 1 Part 2, Phase 1 Part 3, Phase 1 Part 4, Phase 2 Cohort A, Phase 2 Cohort B
INCAGN02390INCAGN02390 administered intravenously	Drug	Phase 1 Part 1, Phase 1 Part 2, Phase 1 Part 3, Phase 1 Part 4, Phase 2 Cohort A, Phase 2 Cohort B
INCMGA00012.INCMGA00012 administered intravenously	Drug	Phase 1 Part 2, Phase 1 Part 3, Phase 1 Part 4, Phase 2 Cohort A, Phase 2 Cohort B

Primary outcome

Phase 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
Time frame: up to 1148 days
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as an AE either reported for the first time or the worsening of a pre-existing event, after the first dose of study drug until 90 days after the last dose of study drug.
Phase 1: Number of Participants With Any ≥Grade 3 TEAE
Time frame: up to 1148 days
The severity of AEs was assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grades 1 through 5. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal. An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A TEAE was defined as an AE reported either reported for the first time or the worsening of a pre-existing event, after the first dose of study drug until 90 days after the last dose of study drug.

10 secondary outcomes

Phase 2: Objective Response Rate (ORR)
Time frame: up to 325 days
Phase 2: Duration of Response (DOR)
Time frame: up to 325 days
Phase 2: Disease Control Rate (DCR)
Time frame: up to 325 days beyond Day 56
Phase 2: Progression-free Survival (PFS)
Time frame: up to 325 days
Phase 2: Number of Participants With Any TEAE
Time frame: up to 415 days
Phase 2: Number of Participants With Any ≥Grade 3 TEAE
Time frame: up to 415 days
Phase 1: ORR
Time frame: up to 1058 days
Phase 1: DOR
Time frame: up to 1058 days
Phase 1: DCR
Time frame: up to 1058 days beyond Day 56
Phase 1: PFS
Time frame: up to 1058 days

Results and safety

Results posted to the registry on 17 Aug 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Phase 1, Part 1: Tuparstobart 350 mg Q2W + Verzistobart 400 mg Q2W	10	0
Phase 1, Part 2: Tuparstobart 350 mg Q2W + Verzistobart 400 mg Q2W + Retifanlimab 500 mg Q4W	11	0
Phase 1, Part 3: Tuparstobart 450 mg Q3W; Tuparstobart 450 mg Q3W + Retifanlimab 375 mg Q3W	6	0
Phase 1, Part 3: Tuparstobart 750 mg Q3W; Tuparstobart 750 mg Q3W + Retifanlimab 375 mg Q3W	6	0
Phase 1, Part 3: Verzistobart 500 mg Q3W; Verzistobart 500 mg Q3W + Retifanlimab 375 mg Q3W	6	0
Phase 1, Part 3: Verzistobart 1000 mg Q3W; Verzistobart 1000 mg Q3W + Retifanlimab 375 mg Q3W	6	0
Phase 2, Cohort A: Tuparstobart 350 mg Q2W + Verzistobart 400 mg Q2W + Retifanlimab 500 mg Q4W	16	0

Primary outcome: Phase 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)

Time frame: up to 1148 days. Count of participants. Unit: Participants

Measure	Phase 1, Part 1: Tuparstobart 350 mg Q2W + Verzistobart 400 mg Q2W n = 10	Phase 1, Part 2: Tuparstobart 350 mg Q2W + Verzistobart 400 mg Q2W + Retifanlimab 500 mg Q4W n = 11	Phase 1, Part 3: Tuparstobart 450 mg Q3W; Tuparstobart 450 mg Q3W + Retifanlimab 375 mg Q3W n = 6	Phase 1, Part 3: Tuparstobart 750 mg Q3W; Tuparstobart 750 mg Q3W + Retifanlimab 375 mg Q3W n = 6	Phase 1, Part 3: Verzistobart 500 mg Q3W; Verzistobart 500 mg Q3W + Retifanlimab 375 mg Q3W n = 6	Phase 1, Part 3: Verzistobart 1000 mg Q3W; Verzistobart 1000 mg Q3W + Retifanlimab 375 mg Q3W n = 6
Value	8	11	6	5	6	5

Population analysed: Full Analysis Set: all participants enrolled in the study who received at least 1 dose of assigned study treatment

Primary outcome: Phase 1: Number of Participants With Any ≥Grade 3 TEAE

Time frame: up to 1148 days. Count of participants. Unit: Participants

Measure	Phase 1, Part 1: Tuparstobart 350 mg Q2W + Verzistobart 400 mg Q2W n = 10	Phase 1, Part 2: Tuparstobart 350 mg Q2W + Verzistobart 400 mg Q2W + Retifanlimab 500 mg Q4W n = 11	Phase 1, Part 3: Tuparstobart 450 mg Q3W; Tuparstobart 450 mg Q3W + Retifanlimab 375 mg Q3W n = 6	Phase 1, Part 3: Tuparstobart 750 mg Q3W; Tuparstobart 750 mg Q3W + Retifanlimab 375 mg Q3W n = 6	Phase 1, Part 3: Verzistobart 500 mg Q3W; Verzistobart 500 mg Q3W + Retifanlimab 375 mg Q3W n = 6	Phase 1, Part 3: Verzistobart 1000 mg Q3W; Verzistobart 1000 mg Q3W + Retifanlimab 375 mg Q3W n = 6
Value	5	6	3	4	2	2

Population analysed: Full Analysis Set

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: up to approximately 5 years. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Phase 1, Part 1: Tuparstobart 350 mg Q2W + Verzistobart 400 mg Q2W	4 of 10 (40%)	8 of 10 (80%)	9 of 10
Phase 1, Part 2: Tuparstobart 350 mg Q2W + Verzistobart 400 mg Q2W + Retifanlimab 500 mg Q4W	2 of 11 (18.2%)	11 of 11 (100%)	8 of 11
Phase 1, Part 3: Tuparstobart 450 mg Q3W; Tuparstobart 450 mg Q3W + Retifanlimab 375 mg Q3W	1 of 6 (16.7%)	6 of 6 (100%)	2 of 6
Phase 1, Part 3: Tuparstobart 750 mg Q3W; Tuparstobart 750 mg Q3W + Retifanlimab 375 mg Q3W	4 of 6 (66.7%)	5 of 6 (83.3%)	1 of 6
Phase 1, Part 3: Verzistobart 500 mg Q3W; Verzistobart 500 mg Q3W + Retifanlimab 375 mg Q3W	3 of 6 (50%)	6 of 6 (100%)	3 of 6
Phase 1, Part 3: Verzistobart 1000 mg Q3W; Verzistobart 1000 mg Q3W + Retifanlimab 375 mg Q3W	1 of 6 (16.7%)	5 of 6 (83.3%)	2 of 6
Phase 2, Cohort A: Tuparstobart 350 mg Q2W + Verzistobart 400 mg Q2W + Retifanlimab 500 mg Q4W	2 of 16 (12.5%)	14 of 16 (87.5%)	4 of 16
Total	17 of 61 (27.9%)	55 of 61 (90.2%)	29 of 61

Limitations and caveats (from the sponsor): The sponsor made a strategic decision to discontinue the tuparstobart and verzistobart clinical development programs; this decision was not related to safety concerns. As a result, Phase 1 Part 4 and Phase 2 Cohort B were not enrolled.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

17 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing INCAGN02385, INCAGN02390 and INCMGA00012. in people with Melanoma, run by Incyte Corporation at 17 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) (time frame: up to 1148 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04370704.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.