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

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Updated on 10 May 2022
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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.

 

Details
Condition Advanced Malignancies, Melanoma
Clinical Study IdentifierTX246761
Last Modified on10 May 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Men and women, aged 18 or older
Willingness to provide written informed consent for the study
Phase 1: Participants with locally advanced or metastatic solid tumors for which a PD-1 inhibitor is indicated (locally advanced disease must not be amenable to resection with curative intent) that have failed a PD-1/PD-L1 inhibitor therapy
PD should be based on imaging done at least 4 weeks apart
Phase 2: Participants with histologically confirmed recurrent Stage III and Stage IV melanoma who relapsed during therapy with anti-PD-1 given as adjuvant therapy
Participants should have no more than one prior therapy given as adjuvant treatment
Participants in Stage 1 (n = 13) and Stage 2 (n = 21) of Phase 2 should have documented LAG-3 positive expression (≥ 5%) by IHC
Participants should be documented BRAF mutation negative
Participants must have fresh biopsy available after completing adjuvant therapy or be willing and able to safely undergo pretreatment tumor biopsies (core or excisional)
ECOG performance status 0 or 1
Willingness to avoid pregnancy or fathering children

Exclusion Criteria

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
Administration of colony-stimulating factors within 14 days before study Day 1
Receipt of a live vaccine within 30 days of planned start of study treatment
Receipt of anticancer medications or investigational drugs within the following intervals before the first administration of study treatment
Phase 1
≤ 14 days for chemotherapy, targeted small molecule therapy, or radiation therapy. Participants must also not require chronic use of corticosteroids and must not have had radiation pneumonitis as a result of treatment. A 1-week washout is permitted for palliative radiation to non-CNS disease with medical monitor approval
≤ 14 days and resolution of all associated toxicities for prior immunotherapy or persistence of active cellular therapy c. < 14 days for prior PD-1 pathway-targeted agents (for Phase 1 and Phase 2)
≤ 28 days for a prior mAb used for anticancer therapy with the exception of PD-1 pathway-targeted agents and denosumab
≤ 7 days for immune-suppressive-based treatment for any reason. f. ≤ 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
Has not recovered to ≤ Grade 1 from toxic effects of prior therapy (including prior immunotherapy) and/or complications from prior surgical intervention before starting therapy
Phase 2
Receipt of any anticancer medication other than adjuvant anti-PD-1 therapy
Receipt of PD-1 pathway-targeted inhibitors within 14 days before the first administration of study treatment
Unknown LAG-3 status or LAG-3 positive > 0% but < 5%
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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