Personalized Immunotherapy in Adults With Advanced Cancers Immunotherapy in Adults With Advanced Cancers

Part of paid clinical trials in San Diego, California.

Sponsor
Aaron Miller
Study ID
NCT03568058
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Cancer

Eligibility Criteria

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

Interventions

  • Personalized Vaccine — DRUG
    Vaccine was constructed for each subject that express multiple candidate tumor-derived neoantigens. Administered intramuscular injection every 3 weeks.
  • Pembrolizumab — DRUG
    Pembrolizumab was administered intravenous (IV) infusion every 3 weeks.

Study Details

The purpose of this study is to determine if it is possible to make and administer safely a 'personalized' vaccine to treat patients that have been diagnosed with advanced cancer and are not candidates for curative therapy.

Key Dates

Start date
Jul 26, 2018
Status verified
Mar 2026
Primary completion
Dec 12, 2022
Completion
Jan 27, 2025

Study Design

Enrollment
25 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: Personalized vaccine and anti- PD-1 administered concurrently at the start of study therapy.
    Personalized vaccine and anti- PD-1 administered concurrently at the start of study therapy. Personalized vaccine will be administered by subcutaneous injection. Vaccine will be administered every three weeks for a total of three doses. Vaccine may continue to be administered at 3 week intervals for an additional 9 doses if there is no evidence of disease progression. Treatment for up to 9 doses may continue past progression if the treating physician feels there is continued benefit.
  • Experimental: Arm B: Anti-PD-1 antibody for 6 weeks followed by personalized vaccine therapy.
    Anti-PD-1 antibody for 6 weeks followed by personalized vaccine therapy. Personalized vaccine will be administered by subcutaneous injection. Vaccine will be administered every three weeks for a total of three doses. Vaccine may continue to be administered at 3 week intervals for an additional 9 doses if there is no evidence of disease progression. Treatment for up to 9 doses may continue past progression if the treating physician feels there is continued benefit.
  • Experimental: Arm C: Personalized vaccine & anti- PD-1 administered concurrently in a boosted schedule
    Personalized vaccine and anti- PD-1 administered concurrently in a boosted schedule at the start of study therapy. Personalized vaccine will be administered by intramuscular injection. Vaccine will be administered three weekly priming vaccine doses, followed by six vaccine doses administered every three weeks. Vaccine may continue to be administered at 3 week intervals for an additional 18 doses if there is no evidence of disease progression. Treatment for up to 9 doses may continue past progression if the treating physician feels there is continued benefit.
  • Experimental: Arm D: Personalized vaccine alone, in a boosted schedule at the start of study therapy.
    Personalized vaccine alone, in a boosted schedule at the start of study therapy. Personalized vaccine will be administered by intramuscular injection. Vaccine will be administered three weekly priming vaccine doses, followed by six vaccine doses administered every three weeks. Vaccine may continue to be administered at 3 week intervals for an additional 18 doses if there is no evidence of disease progression. Treatment for up to 9 doses may continue past progression if the treating physician feels there is continued benefit.

Primary Outcome Measure

Treatment-related Adverse Events [ Time Frame: 1 year ]

Locations (1)

FacilityCityStateZIPSite coordinators
UCSD Medical CenterSan DiegoCalifornia92103-

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By research site
UCSD Medical Center· San Diego, CA

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