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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
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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
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Secondary ID [1]
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GO-004
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Non Small Cell Lung Cancer
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Colorectal Cancer
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Gastroesophageal Adenocarcinoma
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Urothelial Carcinoma
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Condition category
Condition code
Cancer
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Kidney
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Cancer
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Bladder - transitional cell cancer
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - GRT-C901
Other interventions - GRT-R902
Other interventions - nivolumab
Other interventions - ipilimumab
Experimental: Phase 1 - GRT-C901
GRT-R902
nivolumab
ipilimumab
Experimental: Phase 2 Cohorts - GRT-C901
GRT-R902
nivolumab
ipilimumab
Other interventions: GRT-C901
a patient-specific neoantigen cancer vaccine prime
Other interventions: GRT-R902
a patient-specific neoantigen cancer vaccine boost
Other interventions: nivolumab
anti-PD-1 monoclonal antibody
Other interventions: ipilimumab
anti-CTLA-4 monoclonal antibody
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Incidence of adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs)
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Assessment method [1]
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Timepoint [1]
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Initiation of study treatment through 100 days post-last dose (up to approximately 27 months)
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Primary outcome [2]
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Objective Response Rate (ORR) in Phase 2 using RECIST v1.1
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Assessment method [2]
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Timepoint [2]
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Initiation of study treatment until disease progression (up to approximately 27 months)
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Primary outcome [3]
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Identify the recommended Phase 2 dose (RP2D) of GRT-C901 and GRT-R902
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Assessment method [3]
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Timepoint [3]
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Up to approximately 6 months
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Secondary outcome [1]
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Measure the immune response to neoantigens encoded by GRT-C901 and GRT-R902
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Assessment method [1]
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Timepoint [1]
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Baseline to end of treatment (up to approximately 12 months)
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Secondary outcome [2]
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Objective Response Rate (ORR) in Phase 1 using RECIST v1.1
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Assessment method [2]
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Timepoint [2]
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Initiation of study treatment until disease progression (up to approximately 4 years)
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Secondary outcome [3]
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Duration of response (DOR) using RECIST v1.1
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Assessment method [3]
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Timepoint [3]
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Initiation of study treatment until disease progression (up to approximately 4 years)
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Secondary outcome [4]
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Clinical benefit rate (using RECIST v1.1)
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Assessment method [4]
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Timepoint [4]
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Initiation of study treatment until disease progression (up to approximately 4 years)
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Secondary outcome [5]
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Progression-free survival (PFS)
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Assessment method [5]
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Timepoint [5]
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Up to approximately 4 years
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Secondary outcome [6]
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Overall survival (OS)
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Assessment method [6]
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Timepoint [6]
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Up to approximately 4 years
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Secondary outcome [7]
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Percentage of patients for whom vaccine is successfully manufactured and timeframe for vaccine manufacturing
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Assessment method [7]
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Timepoint [7]
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Study enrollment to initiation of study treatment (up to approximately 6 months)
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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)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1/Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
13/02/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
10/11/2022
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Sample size
Target
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Accrual to date
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Final
29
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Peter MacCallum Cancer Centre - Melbourne
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Recruitment postcode(s) [1]
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3000 - Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arizona
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Country [2]
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United States of America
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State/province [2]
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Florida
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Country [3]
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United States of America
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State/province [3]
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Illinois
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Country [4]
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United States of America
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State/province [4]
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Minnesota
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Country [5]
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United States of America
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State/province [5]
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New York
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Country [6]
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United States of America
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State/province [6]
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Ohio
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Country [7]
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United States of America
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State/province [7]
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Tennessee
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Country [8]
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United States of America
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State/province [8]
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Texas
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Country [9]
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United States of America
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State/province [9]
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Virginia
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Gritstone bio, Inc.
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Address
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Bristol-Myers Squibb
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Address [1]
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03639714
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03639714
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