Phase
Condition
Skin Cancer
Lung Cancer
Osteosarcoma
Treatment
Opdualag
KEYTRUDA ®( Pembrolizumab)
KB707
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Histologically confirmed diagnosis of a locally advanced or metastatic solid tumorand the individual has progressed on standard of care therapy, cannot toleratestandard of care therapy, refused standard of care therapy, or there is no standardof care therapy.
Age 12 years or older at the time of informed consent
Life expectancy >12 weeks
ECOG performance status of 0 or 1
Have measurable disease per RECIST v1.1 at Screening
Cohorts 5 and 6 only: Histologically confirmed stage III (unresectable) or stage IVmelanoma, as per American Joint Committee on Cancer (AJCC) staging system (8thedition; AJCC 2017) and
Subject has previously failed one prior anti-PD-1/PD-L1 treatment (asmonotherapy or in combination with other checkpoint inhibitors such asanti-LAG-3 or anti-CTLA-4); and
If proto-oncogene B-Raf (BRAF) V600 mutation-positive, subject previouslyfailed a BRAF inhibitor or BRAF inhibitor in combination with mitogen-activatedextracellular signal-regulated kinase (MEK) inhibitor
Cohort 5 only: Age 12 years or older at the time of informed consent
Cohort 6 only: Age 18 years or older at the time of informed consent
Exclusion
Key Exclusion Criteria:
Prior surgery or radiation therapy must be fully recovered, including all radiation -related toxicities and subject does not require systemic corticosteroids
The subject is pregnant, nursing, or plans to become pregnant during study treatmentand through three months after the last dose of KB707
Have known history of positive human immunodeficiency virus (HIV 1/2)
Cohorts 5 and 6 only:
Subject has a known additional malignancy that is progressing or requiresactive treatment.
Subject has uveal/ocular melanoma.
The subject has active brain metastases or leptomeningeal metastases
Subject has received more than 2 lines of systemic therapy for unresectable ormetastatic melanoma
Prior anti-LAG-3 and/or anti-PD-1 therapy was intolerable and requireddiscontinuation of treatment
Study Design
Study Description
Connect with a study center
UCLA Health
Los Angeles, California 90095
United StatesActive - Recruiting
Stanford Cancer Center
Palo Alto, California 94305
United StatesActive - Recruiting
Mission Dermatology Center
Rancho Santa Margarita, California 92688
United StatesActive - Recruiting
IU Simon Comprehensive Cancer Center
Indianapolis, Indiana 46202
United StatesActive - Recruiting
Henry Ford Cancer Institute
Detroit, Michigan 48202
United StatesSite Not Available
Morristown Medical Center / Atlantic Health System
Morristown, New Jersey 07960
United StatesActive - Recruiting
Weill Cornell Medicine-New York-Presbyterian Hospital
New York, New York 10065
United StatesActive - Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio 45229
United StatesActive - Recruiting
Cleveland Clinic
Cleveland, Ohio 44195
United StatesActive - Recruiting
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania 15232
United StatesActive - Recruiting
Sarah Cannon Research Institute
Nashville, Tennessee 37203
United StatesActive - Recruiting
Renovatio Clinical - El Paso
El Paso, Texas 79915
United StatesActive - Recruiting
MD Anderson Cancer Center
Houston, Texas 77030
United StatesActive - Recruiting
Renovatio Clinical - The Woodlands
The Woodlands, Texas 77380
United StatesActive - Recruiting
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