JTX-2011 Alone and in Combination With Anti-PD-1 or Anti-CTLA-4 in Subjects With Advanced and/or Refractory Solid Tumors

Part of paid clinical trials in Palo Alto, California.

Sponsor
Jounce Therapeutics, Inc.
Study ID
NCT02904226
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Cancer

Eligibility Criteria

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

Interventions

  • JTX-2011 — DRUG
    Specified dose on specified days
  • Nivolumab — DRUG
    Specified dose on specified days
  • Ipilimumab — DRUG
    Specified dose on specified days
  • Pembrolizumab — DRUG
    Specified dose on specified days

Study Details

JTX-2011-101 is a Phase 1/2, open label, dose escalation and expansion clinical study of JTX-2011 alone and in combination with nivolumab, ipilimumab, or pembrolizumab in adult subjects with advanced and/or refractory solid tumors, to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), as well as to evaluate preliminary efficacy.

Key Dates

Start date
Aug 31, 2016
Status verified
Jun 2023
Primary completion
Jul 1, 2020
Completion
Jul 1, 2020

Study Design

Enrollment
242 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A (JTX-2011)
    Phase 1 dose escalation and expansion of JTX-2011 by intravenous (IV) infusion
  • Experimental: Part B (JTX-2011 + nivolumab)
    Phase 1 dose escalation and expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion
  • Experimental: Part C (JTX-2011)
    Phase 2 expansion of JTX-2011 by IV infusion
  • Experimental: Part D (JTX-2011 + nivolumab)
    Phase 2 expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion
  • Experimental: Part E (JTX-2011 + ipilimumab)
    Phase 1 dose escalation of JTX-2011 by IV infusion in combination with ipilimumab by IV infusion
  • Experimental: Part F (JTX-2011 + ipilimumab)
    Phase 2 expansion of JTX-2011 by IV infusion in combination with ipilimumab by IV infusion
  • Experimental: Part G (JTX-2011 + pembrolizumab)
    Phase 1 dose escalation of JTX-2011 by IV infusion in combination with pembrolizumab by IV infusion
  • Experimental: Part H (JTX-2011 + pembrolizumab)
    Phase 2 expansion of JTX-2011 by IV infusion in combination with pembrolizumab by IV infusion

Primary Outcome Measure

Number of Participants With Treatment Emergent Adverse Events (TEAE) [ Time Frame: 46.3 months ]

Locations (16)

FacilityCityStateZIPSite coordinators
Stanford University School of MedicinePalo AltoCalifornia94304-
Sarah Cannon Research Institute at HealthONEDenverColorado80218-
Yale New Haven HospitalNew HavenConnecticut06510-
Georgetown Lombardi Comprehensive Cancer CenterWashington D.C.District of Columbia20007-
The University of Chicago Medicine Comprehensive Cancer CenterChicagoIllinois60637-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-
Washington University School of MedicineSt LouisMissouri63110-
Memorial Sloan Kettering MonmouthMiddletownNew Jersey07748-
Memorial Sloan Kettering WestchesterHarrisonNew York10604-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Sarah Cannon Research Institute at TriStar HealthNashvilleTennessee37203-
The University of Texas - MD Anderson Cancer CenterHoustonTexas77030-
South Texas Accelerated Research Therapeutics, LLCSan AntonioTexas78229-
University of WashingtonSeattleWashington98109-

Find similar trials in Palo Alto, CA

By research site
Stanford University School of Medicine· Palo Alto, CASarah Cannon Research Institute at HealthONE· Denver, COYale New Haven Hospital· New Haven, CTGeorgetown Lombardi Comprehensive Cancer Center· Washington D.C., DCThe University of Chicago Medicine Comprehensive Cancer Center· Chicago, ILBeth Israel Deaconess Medical Center· Boston, MA

Related Studies