A Safety, Tolerability and Efficacy Study of NC410 Plus Pembrolizumab in Participants With Advanced Unresectable or Metastatic Solid Tumors

Part of paid clinical trials in Tucson, Arizona.

Sponsor
NextCure, Inc.
Study ID
NCT05572684
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • NC410 — DRUG
    NC410 will be given intravenously (IV) every 2 weeks
  • pembrolizumab — DRUG
    Pembrolizumab 400mg will be given IV every 6 weeks.

Study Details

This is an open-label, non-randomized, Phase 1b/2 study to determine the safety and tolerability of NC410 when combined with a standard dose of pembrolizumab. This study will also assess the clinical benefit of combination therapy in participants with advanced unresectable and/or metastatic ICI refractory solid tumors OR ICI naïve MSS/MSI-low solid tumors

Key Dates

First listed
Oct 10, 2022
Start date
Oct 6, 2022
Status verified
Jul 2026
Primary completion
Apr 30, 2025
Completion
Apr 30, 2025

Study Design

Enrollment
97 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: NC410 and pembrolizumab
    All participants will receive NC410 (IV) and pembrolizumab (IV) according to the treatment schedule until a reason for treatment discontinuation is reached.

Primary Outcome Measure

Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0 [ Time Frame: From enrollment through up to 90 days after end of treatment, an average of 1 year ]

Locations (17)

FacilityCityStateZIPSite coordinators
Arizona Oncology AssociatesTucsonArizona85711-
Rocky Mountain Cancer CentersAuroraColorado80012-
St. Elizabeth Edgewood HospitalEdgewoodKentucky41017-
Ochsner Cancer InstituteNew OrleansLouisiana70121-
Johns Hopkins Sidney Kimmel Comprehensive Cancer CenterBaltimoreMaryland21231-
Hackensack Meridian Health University Medical Center- John Theurer Cancer CenterHackensackNew Jersey07601-
Roswell Park Comprehensive Cancer CenterBuffaloNew York14203-
NYU Langone HealthNew YorkNew York10016-
University of Cincinnati Cancer CenterCincinnatiOhio45267-
Texas Oncology - Baylor Charles A. Sammons Cancer CenterDallasTexas75246-
UT Southwestern Medical CenterDallasTexas75235-
MD Anderson Cancer CenterHoustonTexas77030-
Texas Oncology - San AntonioSan AntonioTexas78240-
UT Health San AntonioSan AntonioTexas78229-
Inova Schar Cancer InstituteFairfaxVirginia22031-
Virginia Cancer SpecialistFairfaxVirginia22031-
Northwest Cancer SpecialistVancouverWashington98684-

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By research site
Arizona Oncology Associates· Tucson, AZRocky Mountain Cancer Centers· Aurora, COSt. Elizabeth Edgewood Hospital· Edgewood, KYOchsner Cancer Institute· New Orleans, LAJohns Hopkins Sidney Kimmel Comprehensive Cancer Center· Baltimore, MDHackensack Meridian Health University Medical Center- John Theurer Cancer Center· Hackensack, NJ

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