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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03639714




Registration number
NCT03639714
Ethics application status
Date submitted
6/08/2018
Date registered
21/08/2018
Date last updated
13/09/2023

Titles & IDs
Public title
A Study of a Personalized Neoantigen Cancer Vaccine
Scientific title
An International Phase 1/2 Study of GRT-C901/GRT-R902, a Neoantigen Cancer Vaccine, in Combination With Immune Checkpoint Blockade for Patients With Advanced Solid Tumors
Secondary ID [1] 0 0
GO-004
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non Small Cell Lung Cancer 0 0
Colorectal Cancer 0 0
Gastroesophageal Adenocarcinoma 0 0
Urothelial Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Bladder - transitional cell cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - GRT-C901
Treatment: Other - GRT-R902
Treatment: Other - nivolumab
Treatment: Other - ipilimumab

Experimental: Phase 1 - * GRT-C901
* GRT-R902
* nivolumab
* ipilimumab

Experimental: Phase 2 Cohorts - * GRT-C901
* GRT-R902
* nivolumab
* ipilimumab


Treatment: Other: GRT-C901
a patient-specific neoantigen cancer vaccine prime

Treatment: Other: GRT-R902
a patient-specific neoantigen cancer vaccine boost

Treatment: Other: nivolumab
anti-PD-1 monoclonal antibody

Treatment: Other: ipilimumab
anti-CTLA-4 monoclonal antibody
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs)
Timepoint [1] 0 0
Initiation of study treatment through 100 days post-last dose (up to approximately 27 months)
Primary outcome [2] 0 0
Objective Response Rate (ORR) in Phase 2 using RECIST v1.1
Timepoint [2] 0 0
Initiation of study treatment until disease progression (up to approximately 27 months)
Primary outcome [3] 0 0
Identify the recommended Phase 2 dose (RP2D) of GRT-C901 and GRT-R902
Timepoint [3] 0 0
Up to approximately 6 months
Secondary outcome [1] 0 0
Measure the immune response to neoantigens encoded by GRT-C901 and GRT-R902
Timepoint [1] 0 0
Baseline to end of treatment (up to approximately 12 months)
Secondary outcome [2] 0 0
Objective Response Rate (ORR) in Phase 1 using RECIST v1.1
Timepoint [2] 0 0
Initiation of study treatment until disease progression (up to approximately 4 years)
Secondary outcome [3] 0 0
Duration of response (DOR) using RECIST v1.1
Timepoint [3] 0 0
Initiation of study treatment until disease progression (up to approximately 4 years)
Secondary outcome [4] 0 0
Clinical benefit rate (using RECIST v1.1)
Timepoint [4] 0 0
Initiation of study treatment until disease progression (up to approximately 4 years)
Secondary outcome [5] 0 0
Progression-free survival (PFS)
Timepoint [5] 0 0
Up to approximately 4 years
Secondary outcome [6] 0 0
Overall survival (OS)
Timepoint [6] 0 0
Up to approximately 4 years
Secondary outcome [7] 0 0
Percentage of patients for whom vaccine is successfully manufactured and timeframe for vaccine manufacturing
Timepoint [7] 0 0
Study enrollment to initiation of study treatment (up to approximately 6 months)

Eligibility
Key inclusion criteria
* Provide a signed and dated informed consent form prior to initiation of study-specific procedures.
* Patients with the indicated advanced or metastatic solid tumor as follows:

1. NSCLC who are planned for or have received no more than 1 cycle of systemic treatment with cytotoxic, platinum-based chemotherapy (note: patients who have received anti-PD-(L)1 monotherapy are eligible)
2. GEA who are planned for or have received no more than 1 cycle of systemic treatment with cytotoxic, platinum-based chemotherapy
3. mUC who are planned for or have received no more than 1 cycle of systemic treatment with cytotoxic, platinum-based chemotherapy
4. CRC-MSS who are receiving first line systemic therapy or who are planned for or have received no more than 1 cycle of second line systemic therapy including a fluoropyrimidine and oxaliplatin or irinotecan
* 18 years of age or older
* ECOG Performance Status 0 or 1
* Lesion amenable to biopsy
* Measurable disease according to RECIST v1.1
* Have adequate organ function, as measured by laboratory values (criteria listed in protocol)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Tumors with genetic characteristics as follows:

1. For NSCLC, patients with a known genetic driver alteration in EGFR, ALK, ROS1, RET, or TRK
2. For CRC and GEA, patients with known MSI-high disease based on institutional standard
3. For CRC, patients with a known BRAF V600E mutation or patients with peritoneal carcinomatosis and for GEA, patients with peritoneal carcinomatosis as their only evidence of disease
* Patients with known central nervous system (CNS) metastases and/or carcinomatous meningitis
* Known exposure to chimpanzee adenovirus or any history of anaphylaxis in reaction to a vaccination or allergy or hypersensitivity to study drug components
* Bleeding disorder (eg., factor deficiency, coagulopathy) or history of significant bruising or bleeding following IM injections or blood draws

Complete inclusion and exclusion criteria are listed in the clinical study protocol.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/02/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
10/11/2022
Sample size
Target
Accrual to date
Final
29
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Minnesota
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Ohio
Country [7] 0 0
United States of America
State/province [7] 0 0
Tennessee
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
United States of America
State/province [9] 0 0
Virginia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Gritstone bio, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Bristol-Myers Squibb
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the safety, dose, immunogenicity and early clinical activity of GRT-C901 and GRT-R902, a personalized neoantigen cancer vaccine, in combination with nivolumab and ipilimumab, in patients with metastatic non-small cell lung cancer, microsatellite stable colorectal cancer, gastroesophageal adenocarcinoma, and metastatic urothelial cancer.
Trial website
https://clinicaltrials.gov/study/NCT03639714
Trial related presentations / publications
Palmer CD, Rappaport AR, Davis MJ, Hart MG, Scallan CD, Hong SJ, Gitlin L, Kraemer LD, Kounlavouth S, Yang A, Smith L, Schenk D, Skoberne M, Taquechel K, Marrali M, Jaroslavsky JR, Nganje CN, Maloney E, Zhou R, Navarro-Gomez D, Greene AC, Grotenbreg G, Greer R, Blair W, Cao MD, Chan S, Bae K, Spira AI, Roychowdhury S, Carbone DP, Henick BS, Drake CG, Solomon BJ, Ahn DH, Mahipal A, Maron SB, Johnson B, Rousseau R, Yelensky R, Liao CY, Catenacci DVT, Allen A, Ferguson AR, Jooss K. Individualized, heterologous chimpanzee adenovirus and self-amplifying mRNA neoantigen vaccine for advanced metastatic solid tumors: phase 1 trial interim results. Nat Med. 2022 Aug;28(8):1619-1629. doi: 10.1038/s41591-022-01937-6. Epub 2022 Aug 15.
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03639714