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

NCT03568058 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: 180410
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Advanced Cancer

Keywords

immunotherapy; personalized cancer vaccine; personalized immunotherapy; pembrolizumab; Keytruda; cancer; neoantigen; solid tumor; vaccine

Outcome Measures

Primary Outcomes (1)

• Treatment-related Adverse Events

  Number of Treatment-related Adverse Events

  1 year

Secondary Outcomes (1)

• Overall Response

  1 year

Study Arms (4)

Arm A: Personalized vaccine and anti- PD-1 administered concurrently at the start of study therapy.

EXPERIMENTAL

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.

Drug: Personalized Vaccine; Drug: Pembrolizumab

Arm B: Anti-PD-1 antibody for 6 weeks followed by personalized vaccine therapy.

EXPERIMENTAL

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.

Drug: Personalized Vaccine; Drug: Pembrolizumab

Arm C: Personalized vaccine & anti- PD-1 administered concurrently in a boosted schedule

EXPERIMENTAL

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.

Drug: Personalized Vaccine; Drug: Pembrolizumab

Arm D: Personalized vaccine alone, in a boosted schedule at the start of study therapy.

EXPERIMENTAL

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.

Drug: Personalized Vaccine

Interventions

Personalized Vaccine DRUG

Vaccine was constructed for each subject that express multiple candidate tumor-derived neoantigens. Administered intramuscular injection every 3 weeks.

Arm A: Personalized vaccine and anti- PD-1 administered concurrently at the start of study therapy.; Arm B: Anti-PD-1 antibody for 6 weeks followed by personalized vaccine therapy.; Arm C: Personalized vaccine & anti- PD-1 administered concurrently in a boosted schedule; Arm D: Personalized vaccine alone, in a boosted schedule at the start of study therapy.

Pembrolizumab DRUG

Pembrolizumab was administered intravenous (IV) infusion every 3 weeks.

Also known as: Keytruda, Anti- PD-1

Arm A: Personalized vaccine and anti- PD-1 administered concurrently at the start of study therapy.; Arm B: Anti-PD-1 antibody for 6 weeks followed by personalized vaccine therapy.; Arm C: Personalized vaccine & anti- PD-1 administered concurrently in a boosted schedule

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically documented incurable solid tumor \[excluding lymphoma\].
• Measurable disease as defined by RECIST 1.1
• Progressed on or be intolerant to therapies that are known to provide clinical benefit.
• Non-measurable disease by RECIST 1.1 and high-risk (\>50% over 5 years) of mortality
• ECOG Performance Status ≤ 1.
• At least one tumor site accessible for biopsy.
• Adequate organ function
• Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy.

You may not qualify if:

• Patient has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
• Known or suspected allergy or hypersensitivity to any component of vaccine.
• Has a known history of Human Immunodeficiency Virus (HIV).
• Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \[HBsAg\] reactive) or known active Hepatitis C virus (defined as HCV RNA \[qualitative\] is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority. (Individuals who are hepatitis C antibody positive may be enrolled if negative viral load confirmed).
• History of autoimmune disease including: inflammatory bowel disease (including ulcerative colitis and Crohn's Disease), rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythematosus, autoimmune vasculitis (e.g. Wegener's granulomatosis); central nervous system or motor neuropathy considered of autoimmune origin (e.g. Guillain-Barré syndrome, myasthenia gravis, multiple sclerosis). Individuals with vitiligo, Sjogren's Syndrome, interstitial cystitis, Graves' or Hashimoto's Disease, celiac disease, DM1, hypothyroidism stable on hormone replacement, or any autoimmune disease without symptoms and not requiring active therapy for at least 2 years will be allowed with Study Medical Monitor's approval.
• Has a known history of active TB (Bacillus Tuberculosis).
• Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
• History of receiving a solid organ transplant or allogeneic bone marrow transplant.
• Unable or unwilling to withhold or discontinue any prohibited or restricted medications/procedures for the specified windows during the study.

Sponsors & Collaborators

• Aaron Miller: lead

Study Sites (1)

UCSD Medical Center

San Diego, California, 92103, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

pembrolizumab; spartalizumab

Results Point of Contact

• Title: Dr. Aaron Miller
• Organization: University of California, San Diego

CancerCTO@health.ucsd.edu

(858) 822-5354

Study Officials

• Aaron Miller, MD, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: June 13, 2018
• First Posted: June 26, 2018
• Study Start: July 26, 2018
• Primary Completion: December 12, 2022
• Study Completion: January 27, 2025
• Last Updated: March 24, 2026
• Results First Posted: March 24, 2026

Record last verified: 2026-03

Locations

US (1)