Colonic NeoplasmsPhase 2NCT05456165
Study of an Individualized Vaccine Targeting Neoantigens in Combination With Immune Checkpoint Blockade for Patients With Colon Cancer
A Phase 2 study testing GRT-C901, GRT-R902 and Atezolizumab in people with Colonic Neoplasms and Colorectal Neoplasms, run by Gritstone bio, Inc. at 3 sites in United States.
Trial summary
The primary objective is to assess and characterize the antitumor activity and safety and tolerability of adjuvant treatment with an individualized neoantigen vaccine called GRT-C901/GRT-R902 (chimpanzee adenovirus [ChAd] and self-amplifying messenger RNA [samRNA] vectors), in combination with checkpoint inhibitors. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Colonic Neoplasms, Colorectal Neoplasms
- What is being tested?
- GRT-C901, GRT-R902 and Atezolizumab
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 3 sitesUnited States
- Study dates
- 19 May 2022to 1 Sep 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- For Vaccine Production Stage:
- Patients with a high-risk stage II or stage III colon cancer, including high-risk stage II colon cancer defined as meeting any of the following criteria: T4 tumors, Grade ≥3, clinical presentation with bowel obstruction or perforation, histological signs of vascular or lymphatic or perineural invasions, and <12 nodes examined
- Patient has evidence of minimal residual disease (MRD) prior to initiating adjuvant chemotherapy (ACT) based on the presence of ctDNA
- Patient has received approximately <6 weeks of ACT.
- Margin negative (R0) pathology on resection
- Availability of formalin fixed, paraffin embedded (FFPE) tumor specimens
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- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 or equivalent for patients 12 to 17 years of age
- Patient has adequate organ function as defined by: peripheral white blood cell (WBC) count ≥3000/mm^3, absolute lymphocyte count (ALC) ≥800/mm^3, absolute neutrophils count (ANC) ≥1500/mm^3, platelets ≥100,000/mm^3, hemoglobin ≥9 g/dL, albumin ≥3 g/dL, calculated creatinine clearance >50 mL/min using Cockcroft-Gault equation, alanine transaminase (ALT) and aspartate aminotransferase (AST) ≤3 × upper limit of normal (ULN), total serum bilirubin ≤1.5 × ULN OR direct bilirubin ≤1 × ULN, international normalized ratio (INR), prothrombin time (PT), or partial thromboplastin time (PTT) ≤1.5 × ULN, unless patient is receiving anti-coagulant therapy, in which case patients are eligible if PT and PTT are within therapeutic range of intended use of anti-coagulants, and carcinoembryonic antigen levels ≤1.5 × ULN.
- A woman of childbearing potential (WCBP) must be willing to undergo pregnancy testing and agrees to the use at least 1 highly effective contraceptive method during the study treatment period and for 5 months after last investigational study treatment
- For Study Treatment Stage:
- Have a confirmed diagnosis of high-risk stage II or stage III micro-satellite stable (MSS)-colon cancer and have had their tumor surgically resected, have completed standard ACT and have no evidence of disease radiographically, and have evidence of MRD based on detection of ctDNA following ACT
- ECOG performance status of 0 to 1 or equivalent for patients 12-17 years of age
- Have adequate organ function with peripheral WBC count ≥2000/mm^3, ALC ≥500/mm^3, ANC ≥1000/mm^3, platelets ≥75,000/mm^3, hemoglobin ≥9 g/dL, albumin ≥3 g/dL, calculated creatinine clearance >40 mL/min using Cockcroft-Gault equation, ALT and AST ≤3 × ULN, total serum bilirubin ≤1.5 × ULN OR direct bilirubin ≤1 × ULN, and INR, PT, or PTT ≤1.5 × ULN
- If a WCBP, must be willing to undergo pregnancy testing and agrees to the use at least 1 highly effective contraceptive method during the study treatment period and for 5 months after last investigational study treatment
- If male and sexually active with a WCBP, must agree to use highly effective contraception such as latex condom plus partner use of a highly effective contraceptive method during the study treatment period and for 5 months after last investigational study treatment.
Who cannot join
- For Vaccine Production Stage:
- Patients with micro-satellite instable (MSI)-high disease
- Patients with known tumor mutational burden (TMB) <1 non-synonymous mutations/megabase
- Patients with known DNA Polymerase Epsilon mutations
- Known exposure to chimpanzee adenovirus (ChAd) within the prior 6 months, plan to receive a ChAd-based vaccine in the next 6 months, and/or any history or anaphylaxis in reaction to a vaccination
- Bleeding disorder or history of significant bruising or bleeding following intramuscular (IM) injections or blood draws
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- Immunosuppression anticipated at time of study treatment
- Patient has received prior therapy consisting of anti-cytotoxic T lymphocyte-associated antigen (CTLA-4), anti-programmed cell death-1 receptor (PD-1), anti-programmed death ligand-1(PD-L1), or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
- History of allogeneic tissue/solid organ transplant
- Active or history of autoimmune disease or immune deficiency
- History of other cancer within 2 years
- Active tuberculosis or recent (<2 week) clinically significant infection, or evidence of active hepatitis B or hepatitis C or known history of positive test for human immunodeficiency virus (HIV) if CD4+ T-cell count is ≤200 cells/microliter.
- History of pneumonitis requiring systemic steroids for treatment (with the exception of prior resolved in-field radiation pneumonitis)
- Myocardial infarction within 3 months or prior to study treatment, unstable angina, serious uncontrolled cardiac arrhythmia, history of myocarditis, or congestive heart failure (New York Heart Association [NYHA] Grade 3 and 4)
- Pregnant, planning to become pregnant, or nursing
- For Study Treatment Stage
- Patient is receiving treatment with investigational products and/or other anti-cancer therapies.
- Known exposure to ChAd within the prior 6 months, plan to receive a ChAd-based vaccine in the next 6 months, and/or any history or anaphylaxis in reaction to a vaccination
- Immunosuppression from concurrent, recent (≤4 weeks) or anticipated treatment with systemic corticosteroids or other immunosuppressive medications or conditions such as hypogammaglobulinemia, or radiation exposure
- Patients who have not recovered from prior cancer therapy-induced AEs
- Any severe concurrent non-cancer disease
- Active tuberculosis or recent (<2 weeks) clinically significant infection, evidence of active hepatitis B or hepatitis C, or known history of positive test for HIV if CD4+ T-cell count is ≤200 cells/microliter
- History of pneumonitis requiring systemic steroids for treatment
- Myocardial infarction within 6 months prior to initiating study treatment, unstable angina, serious uncontrolled cardiac arrhythmia, history of myocarditis, or congestive heart failure (NYHA Grade 3 and 4).
- Pregnant, planning to become pregnant, or nursing
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Christ Hospital Cancer Center
Cincinnati, Ohio, 45229
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
NYU Langone Health
New York, New York, 10016
About this study
Official title: A Randomized, Open-Label, Phase 2 Study of a Patient-Specific Vaccine Targeting Neoantigens in Combination With Immune Checkpoint Blockade for Patients With Colon Cancer With Minimal Residual Disease Following Surgical Resection and Standard Adjuvant Chemotherapy
The primary objective is to assess and characterize the antitumor activity and safety and tolerability of adjuvant treatment with an individualized neoantigen vaccine called GRT-C901/GRT-R902 (chimpanzee adenovirus [ChAd] and self-amplifying messenger RNA [samRNA] vectors), in combination with checkpoint inhibitors. Antitumor activity will be based on molecular response in patients with colon cancer who have circulating tumor deoxyribonucleic acid (ctDNA) following surgical resection.
Read the detailed description
Tumors harboring non-synonymous deoxyribonucleic acid (DNA) mutations present peptides containing these mutations as non-self antigens in the context of human leukocyte antigens (HLAs) on the tumor cell surface. A fraction of mutated peptides results in neoantigens capable of generating T cell responses that exclusively target tumor cells. Sensitive detection of these mutations allows for the identification of neoantigens unique to each patient's tumor to be included in a personalized cancer vaccine that targets these neoantigens. This vaccine regimen uses two vaccine vectors as a heterologous prime/boost approach (GRT-C901, ChAd as prime and GRT-R902, samRNA as boost) to stimulate an immune response. This study (GRANITE-ADJUVANT) will explore the anti-tumor activity of this individualized, patient specific immunotherapy in combination with checkpoint inhibitors.
- Conditions
- Colonic Neoplasms, Colorectal Neoplasms
- Being tested
- GRT-C901, GRT-R902, Atezolizumab, Ipilimumab, Adjuvant chemotherapy
- Medical subject headings
- Colonic Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GRT-C901Drug
An individualized neoantigen cancer vaccine using an adenovirus vector administered via intramuscular (IM) injections at Visit 1 and boost at Visit 6.
GRT-R902Drug
An individualized neoantigen cancer vaccine using a self-amplifying mRNA (samRNA) vector administered via IM injection at Visits 2, 4, 9, and 12.
AtezolizumabDrug
Dose of 1680 mg administered once every 4 weeks (Q4W) via intravenous (IV) infusion at Visits 1-13.
IpilimumabDrug
Dose of 30 mg administered via subcutaneous (SC) injection only with the first dose of GRT-C901 at Visit 1 and GRTR902 at Visit 2.
Adjuvant chemotherapyDrug
Administered according to standard of care.
| Study group | Role | What they receive |
|---|---|---|
| GRT-C901/GRT-R902 Vaccine arm | Experimental | After surgical resection, patients who are circulating tumor DNA (ctDNA) positive will receive adjuvant chemotherapy for 12-24 weeks during which they will undergo neoantigen prediction, randomization, and vaccine manufacturing. After study treatment screening, patients who are still ctDNA positive with no evidence of residual or metastatic disease will receive a total of 6 doses of GRT-C901/ GRT-R902, 2 doses of ipilimumab, and 13 doses of atezolizumab. Study visits occur every 28 days. Receives: Drug: GRT-C901; Drug: GRT-R902; Drug: Atezolizumab; Drug: Ipilimumab; Drug: Adjuvant chemotherapy |
| Observation arm | Active comparator | After surgical resection, patients who are ctDNA positive will receive adjuvant chemotherapy for 12-24 weeks during which they will undergo neoantigen prediction and randomization. After study treatment screening, patients who are still ctDNA positive with no evidence of residual or metastatic disease will be observed via study visits occur every 12 weeks. Receives: Drug: Adjuvant chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients with a ≥50% Decrease from Baseline in Circulating Tumor deoxyribonucleic acid (ctDNA)
Measured: Baseline and up to ~24 months
Incidence and Severity of Adverse Events
The incidence and severity will be assessed for treatment-emergent adverse events (TEAEs), immune-related AEs (irAEs), treatment-related AEs, serious AEs (SAEs), AEs leading to death while patients are on treatment or up to 100 days after the last study treatment, AEs leading to dose delays or dose discontinuation, and AEs leading to discontinuation of study treatment using National Cancer Institute (NCI) Criteria for Adverse Events (CTCAE) v5.0
Measured: Up to ~100 days after last study treatment (Up to 62 weeks)
Secondary outcomes (7)
Recurrence-free survival (RFS) per Investigator
Measured: From time of randomization until first recurrence of the same cancer, or death (Up to ~36 months)
Disease-free survival (DFS) per Investigator
Measured: From time of randomization until first recurrence of any cancer, or death (Up to ~36 months)
Overall Survival (OS)
Measured: From time of randomization until death due to any cause (Up to ~36 months)
Conversion of Patients with ctDNA at Baseline to Undetectable ctDNA as Assessed via a Polymerase Chain Reaction (PCR)-Based Assay
Measured: Baseline and up to ~24 months
Longest Duration of Molecular response of ctDNA Decrease from Baseline
Measured: Baseline and up to ~24 months
Success of Vaccine Manufacture
Vaccine manufacture success measured by the number of patients having sufficient neoantigens identified to warrant vaccine production.
Measured: Up to 28 days before Day 1 of study drug administration
T-cell response using Peripheral Blood Mononuclear Cells (PBMCs)
Measured: Up to ~24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start19 May 2022
- Primary completion1 Sep 2022
- Study completion1 Sep 2022
Why it stopped: terminated due to reprioritization
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gritstone bio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05456165
- Sponsor's protocol ID
- GO-008
- Other IDs
- GRANITE-ADJUVANT
- Status last verified
- Dec 2024
- First submitted
- 8 Jul 2022
- Last updated
- 31 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Phase 2 Study of a Patient-Specific Vaccine Targeting Neoantigens in Combination With Immune Checkpoint Blockade for Patients With Colon Cancer With Minimal Residual Disease Following Surgical Resection and Standard Adjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT05456165
- Acronym / sponsor ID
- GO-008
- Conditions
- Colonic Neoplasms, Colorectal Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: terminated due to reprioritization
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Gritstone bio, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 May 2022 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 13 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is to assess and characterize the antitumor activity and safety and tolerability of adjuvant treatment with an individualized neoantigen vaccine called GRT-C901/GRT-R902 (chimpanzee adenovirus [ChAd] and self-amplifying messenger RNA [samRNA] vectors), in combination with checkpoint inhibitors. Antitumor activity will be based on molecular response in patients with colon cancer who have circulating tumor deoxyribonucleic acid (ctDNA) following surgical resection.
Detailed description
Tumors harboring non-synonymous deoxyribonucleic acid (DNA) mutations present peptides containing these mutations as non-self antigens in the context of human leukocyte antigens (HLAs) on the tumor cell surface. A fraction of mutated peptides results in neoantigens capable of generating T cell responses that exclusively target tumor cells. Sensitive detection of these mutations allows for the identification of neoantigens unique to each patient's tumor to be included in a personalized cancer vaccine that targets these neoantigens. This vaccine regimen uses two vaccine vectors as a heterologous prime/boost approach (GRT-C901, ChAd as prime and GRT-R902, samRNA as boost) to stimulate an immune response. This study (GRANITE-ADJUVANT) will explore the anti-tumor activity of this individualized, patient specific immunotherapy in combination with checkpoint inhibitors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GRT-C901/GRT-R902 Vaccine arm | Experimental | Drug: GRT-C901, Drug: GRT-R902, Drug: Atezolizumab, Drug: Ipilimumab, Drug: Adjuvant chemotherapyAfter surgical resection, patients who are circulating tumor DNA (ctDNA) positive will receive adjuvant chemotherapy for 12-24 weeks during which they will undergo neoantigen prediction, randomization, and vaccine manufacturing. After study treatment screening, patients who are still ctDNA positive with no evidence of residual or metastatic disease will receive a total of 6 doses of GRT-C901/ GRT-R902, 2 doses of ipilimumab, and 13 doses of atezolizumab. Study visits occur every 28 days. |
| Observation arm | Active comparator | Drug: Adjuvant chemotherapyAfter surgical resection, patients who are ctDNA positive will receive adjuvant chemotherapy for 12-24 weeks during which they will undergo neoantigen prediction and randomization. After study treatment screening, patients who are still ctDNA positive with no evidence of residual or metastatic disease will be observed via study visits occur every 12 weeks. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (15 listed)
- Patients with a high-risk stage II or stage III colon cancer, including high-risk stage II colon cancer defined as meeting any of the following criteria: T4 tumors, Grade ≥3, clinical presentation with bowel obstruction or perforation, histological signs of vascular or lymphatic or perineural invasions, and <12 nodes examined
- Patient has evidence of minimal residual disease (MRD) prior to initiating adjuvant chemotherapy (ACT) based on the presence of ctDNA
- Patient has received approximately <6 weeks of ACT.
- Margin negative (R0) pathology on resection
- Availability of formalin fixed, paraffin embedded (FFPE) tumor specimens
Key exclusion criteria (25 listed)
- Patients with micro-satellite instable (MSI)-high disease
- Patients with known tumor mutational burden (TMB) <1 non-synonymous mutations/megabase
- Patients with known DNA Polymerase Epsilon mutations
- Known exposure to chimpanzee adenovirus (ChAd) within the prior 6 months, plan to receive a ChAd-based vaccine in the next 6 months, and/or any history or anaphylaxis in reaction to a vaccination
- Bleeding disorder or history of significant bruising or bleeding following intramuscular (IM) injections or blood draws
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GRT-C901An individualized neoantigen cancer vaccine using an adenovirus vector administered via intramuscular (IM) injections at Visit 1 and boost at Visit 6. | Drug | GRT-C901/GRT-R902 Vaccine arm |
| GRT-R902An individualized neoantigen cancer vaccine using a self-amplifying mRNA (samRNA) vector administered via IM injection at Visits 2, 4, 9, and 12. | Drug | GRT-C901/GRT-R902 Vaccine arm |
| AtezolizumabDose of 1680 mg administered once every 4 weeks (Q4W) via intravenous (IV) infusion at Visits 1-13. | Drug | GRT-C901/GRT-R902 Vaccine arm |
| IpilimumabDose of 30 mg administered via subcutaneous (SC) injection only with the first dose of GRT-C901 at Visit 1 and GRTR902 at Visit 2. | Drug | GRT-C901/GRT-R902 Vaccine arm |
| Adjuvant chemotherapyAdministered according to standard of care. | Drug | GRT-C901/GRT-R902 Vaccine arm, Observation arm |
Primary outcome
Percentage of Patients with a ≥50% Decrease from Baseline in Circulating Tumor deoxyribonucleic acid (ctDNA)
Time frame: Baseline and up to ~24 months
Incidence and Severity of Adverse Events
Time frame: Up to ~100 days after last study treatment (Up to 62 weeks)
The incidence and severity will be assessed for treatment-emergent adverse events (TEAEs), immune-related AEs (irAEs), treatment-related AEs, serious AEs (SAEs), AEs leading to death while patients are on treatment or up to 100 days after the last study treatment, AEs leading to dose delays or dose discontinuation, and AEs leading to discontinuation of study treatment using National Cancer Institute (NCI) Criteria for Adverse Events (CTCAE) v5.0
7 secondary outcomes
Recurrence-free survival (RFS) per Investigator
Time frame: From time of randomization until first recurrence of the same cancer, or death (Up to ~36 months)
Disease-free survival (DFS) per Investigator
Time frame: From time of randomization until first recurrence of any cancer, or death (Up to ~36 months)
Overall Survival (OS)
Time frame: From time of randomization until death due to any cause (Up to ~36 months)
Conversion of Patients with ctDNA at Baseline to Undetectable ctDNA as Assessed via a Polymerase Chain Reaction (PCR)-Based Assay
Time frame: Baseline and up to ~24 months
Longest Duration of Molecular response of ctDNA Decrease from Baseline
Time frame: Baseline and up to ~24 months
Success of Vaccine Manufacture
Time frame: Up to 28 days before Day 1 of study drug administration
T-cell response using Peripheral Blood Mononuclear Cells (PBMCs)
Time frame: Up to ~24 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GRT-C901, GRT-R902 and Atezolizumab in people with Colonic Neoplasms and Colorectal Neoplasms, run by Gritstone bio, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 31 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients with a ≥50% Decrease from Baseline in Circulating Tumor deoxyribonucleic acid (ctDNA) (time frame: Baseline and up to ~24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2024.