Pembrolizumab and Recombinant Interleukin-12 in Treating Patients With Solid Tumors

Part of paid clinical trials in Sacramento, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT03030378
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Metastatic Malignant Solid Neoplasm
  • Unresectable Malignant Solid Neoplasm

Eligibility Criteria

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

Interventions

  • Biopsy Procedure — PROCEDURE
    Undergo a tumor biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood
  • Computed Tomography — PROCEDURE
    Undergo a CT scan
  • Edodekin alfa — BIOLOGICAL
    Given SC
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo a MRI
  • Pembrolizumab — BIOLOGICAL
    Given IV
  • Positron Emission Tomography — PROCEDURE
    Undergo a PET scan

Study Details

This phase I trial studies the side effects and best dose of pembrolizumab and recombinant interleukin-12 in treating patients with solid tumors. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Recombinant interleukin-12 may kill tumor cells by blocking blood flow to the tumor and by stimulating white blood cells to kill tumor cells. Giving pembrolizumab and recombinant interleukin-12 may work better than giving pembrolizumab alone in treating patients with solid tumors.

Key Dates

Start date
May 30, 2018
Status verified
May 2026
Primary completion
Dec 1, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
36 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (recombinant interleukin-12, pembrolizumab)
    Patients receive recombinant interleukin-12 SC on days 2, 5, 9, and 12 and pembrolizumab IV over 30 minutes on day 8 of cycle 1 and day 1 of subsequent cycles. Treatment continues for 28 days for cycle 1 and repeats every 21 days for subsequent cycles for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Patient then receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 8 additional cycles in the absence of disease progression or unacceptable toxicity. Patients undergo a CT, PET, and MRI, as well as collection of blood during screening, on study, and during follow-up. Patients also undergo a tumor biopsy during screening and on study.

Primary Outcome Measure

Maximum tolerated dose (MTD) [ Time Frame: Up to 5 years ]

Locations (27)

FacilityCityStateZIPSite coordinators
University of California Davis Comprehensive Cancer CenterSacramentoCalifornia95817-
UCSF Medical Center-Mount ZionSan FranciscoCalifornia94115-
UCHealth University of Colorado HospitalAuroraColorado80045-
Smilow Cancer Center/Yale-New Haven HospitalNew HavenConnecticut06510-
Yale UniversityNew HavenConnecticut06520-
UF Health Cancer Institute - GainesvilleGainesvilleFlorida32610-
Emory Saint Joseph's HospitalAtlantaGeorgia30342-
Emory University Hospital MidtownAtlantaGeorgia30308-
Emory University Hospital/Winship Cancer InstituteAtlantaGeorgia30322-
University of Iowa/Holden Comprehensive Cancer CenterIowa CityIowa52242-
Johns Hopkins University/Sidney Kimmel Cancer CenterBaltimoreMaryland21287-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Brigham and Women's HospitalBostonMassachusetts02115-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General Hospital Cancer CenterBostonMassachusetts02114-
Siteman Cancer Center at Saint Peters HospitalCity of Saint PetersMissouri63376-
Siteman Cancer Center at West County HospitalCreve CoeurMissouri63141-
Siteman Cancer Center at Christian HospitalSt LouisMissouri63136-
Siteman Cancer Center-South CountySt LouisMissouri63129-
Washington University School of MedicineSt LouisMissouri63110-
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08903-
UNC Lineberger Comprehensive Cancer CenterChapel HillNorth Carolina27599-
Duke University Medical CenterDurhamNorth Carolina27710-
Cleveland Clinic FoundationClevelandOhio44195-
University of Pittsburgh Cancer Institute (UPCI)PittsburghPennsylvania15232-
University of Texas Health Science Center at San AntonioSan AntonioTexas78229-
VCU Massey Comprehensive Cancer CenterRichmondVirginia23298-

Find similar trials in Sacramento, CA

By research site
University of California Davis Comprehensive Cancer Center· Sacramento, CAUCSF Medical Center-Mount Zion· San Francisco, CAUCHealth University of Colorado Hospital· Aurora, COSmilow Cancer Center/Yale-New Haven Hospital· New Haven, CTYale University· New Haven, CTUF Health Cancer Institute - Gainesville· Gainesville, FL

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