Colorectal CancerPhase 2NIVO402025NCT07542262
Low-dose Immunotherapy in Metastatic and Locally Advanced Colorectal and Gastric MSI/dMMR Cancers
A Phase 2 study testing Low-dose nivolumab, Low-dose nivolumab with/without chemotherapy and Low-dose nivolumab combined with chemotherapy in people with Colorectal Cancer and Gastric Cancer, run by Blokhin's Russian Cancer Research Center at 1 site in Russia.
Trial summary
It is planned to study the effectiveness of low-dose immunotherapy (IT) nivolumab 40 mg for either 2 courses of therapy or 6 courses as preoperative therapy in patients with dMMR/MSI locally advanced CRC. Parallel recruitment into subgroups of patients by randomization is assumed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Gastric Cancer
- What is being tested?
- Low-dose nivolumab, Low-dose nivolumab with/without chemotherapy and Low-dose nivolumab combined with chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteRussia
- Study dates
- 3 Jun 2025to 31 Mar 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Availability of voluntarily signed informed consent from the patient;
- Men and women, 18 years old </=;
- Histologically confirmed adenocarcinoma of the colon/rectum/stomach;
- Presence of MSI/dMMR in the tumor;
- For M0-cohort: locally advanced tumor - cT3-4N0-2M0 according to CT for tumors of the colon and sigmoid colon; cT3 with a depth of tissue invasion ≥5mm (cT2N0 and higher for lower ampullary cancer) or T4 or involvement of the lateral resection margins according to MRI for rectal cancer; for gastric cancer: cT2</=, N0-3, no presence of tumour cells in peritoneum (cyt-);
- For M1-cohort: non-resectable locally-advanced, metastatic disease
- ECOG 0-2;
- No contraindications to surgical treatment of malignancy
Who cannot join
- Previous therapy with the inclusion of monoclonal antibodies - anti-PD1, anti-PD-L1, anti PD-L2, anti-CTLA4 antibodies and other immunotherapy drugs
- The presence of any other malignant tumor, with the exception of radically treated basal cell carcinoma, cervical cancer in situ, currently or within 5 years before inclusion in the study
- Pregnant and lactating women, as well as planning pregnancy during the period of therapy in a clinical trial and 6 months after the end of therapy
- Patients with preserved reproductive potential who refuse to use adequate methods of contraception throughout the study and 6 months after the end of therapy or who agree to abstain from heterosexual contact.
- Previous systemic therapy with immunosuppressive drugs (including, but not limited to: prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide and TNF [tumor necrosis factor] antagonists) within 4 weeks before signing the informed consent form, or the need to use immunosuppressive therapy in during the first year of the study.
- The use of systemic glucocorticosteroids (GCS) in replacement doses (for example, in a dose equivalent to 10 mg of prednisolone per day or less), short-term use of systemic GCS (≤7 days), inhaled and topical GCS are allowed.
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- Active, known or suspected autoimmune diseases (patients with type 1 diabetes mellitus and hypothyroidism requiring only hormone replacement therapy, as well as autoimmune diseases with only skin manifestations [for example, vitiligo, alopecia or psoriasis without symptoms of psoriatic arthritis] are allowed to participate), that do not require systemic therapy);
- Patients with HIV infection, active hepatitis B, active hepatitis C.
- Life expectancy less than 6 months.
- The presence of a disease or condition that, in the opinion of the investigator, prevents the patient from participating in the study.
- Complicated course of the primary tumor, requiring urgent surgical intervention.
- Previously performed radiation or chemotherapy for colorectal cancer or gastric cancer, with the exception of cases of metachronous tumors over 5 years ago;
- Persistence, progression or recurrence of the underlying disease or the presence of distant metastases
- Conditions limiting the patient's ability to comply with the requirements of the protocol (in the opinion of the investigator);
- Vaccination with live vaccines within 28 days before randomization;
- Participation in other interventional clinical trials less than 30 days before randomization (except in cases of dropout before the introduction of study therapy) and while participating in an ongoing clinical trial;
- Significant adverse events from previous therapy, with the exception of chronic and/or irreversible events that cannot influence the assessment of the safety of the study therapy (for example, alopecia);
- Hypersensitivity or allergic reactions to the administration of drugs manufactured using Chinese hamster ovary cells, severe allergic reactions, anaphylaxis or other hypersensitivity reactions to chimeric or humanized antibodies, or any of the components of the study drug.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Phase II Open-lable Single-center Clinical Study of the Efficacy and Safety of Low-dose Immunotherapy in the Treatment of Patients With Metastatic and Locally Advanced Colorectal and Gastric Cancers With Microsatellite Unstable Phenotype (MSI)/Deficiency of Mismatch Repair System (dMMR)
It is planned to study the effectiveness of low-dose immunotherapy (IT) nivolumab 40 mg for either 2 courses of therapy or 6 courses as preoperative therapy in patients with dMMR/MSI locally advanced CRC. Parallel recruitment into subgroups of patients by randomization is assumed.
For dMMR/MSI locally advanced gastric cancer, it is planned to study the effectiveness of low-dose immunotherapy nivolumab 40 mg with or without the addition of chemotherapy (CT) in the FOLFOX regimen as preoperative therapy.
Read more
Subgroup A includes 6 cycles of IV CT FOLFOX + IV administration of nivolumab 40 mg once every 14 days, subgroup B - 2 cycles of intravenous administration of nivolumab at a dose of 40 mg once every 14 days, and subgroup C - 6 cycles of intravenous administration of nivolumab at a dose of 40 mg once a day 14 days. Thus, it is planned to gradually include patients in the treatment subgroups.
The frequency of complete therapeutic tumor pathomorphoses (pCR, TRG1) will be evaluated as the primary endpoint. Secondary goals are to study the safety of drug doses, to assess the frequency of pronounced therapeutic tumor pathomorphoses (MPR, TRG 1-2), to assess disease-free survival (PFS), the frequency of R0 resections, overall survival(S), and the frequency of objective response.
To study the use of low-dose immunotherapy in combination with chemotherapy in patients with metastatic dMMR/MSI CRC and gastric cancer in the first line of therapy, it is planned to use a combination of nivolumab 40 mg with FOLFOX regimen once every 14 days for 8 treatment cycles, followed by a switch to supportive intravenous monotherapy with nivolumab 40 mg.
Read the detailed description
It is planned to study the effectiveness of low-dose immunotherapy (IT) nivolumab 40 mg for either 2 courses of therapy or 6 courses as preoperative therapy in patients with dMMR/MSI locally advanced CRC. Parallel recruitment into subgroups of patients by randomization is assumed.
For dMMR/MSI locally advanced gastric cancer, it is planned to study the effectiveness of low-dose immunotherapy nivolumab 40 mg with or without the addition of chemotherapy (CT) in the FOLFOX regimen as preoperative therapy.
Subgroup A includes 6 cycles of IV CT FOLFOX + IV administration of nivolumab 40 mg once every 14 days, subgroup B - 2 cycles of intravenous administration of nivolumab at a dose of 40 mg once every 14 days, and subgroup C - 6 cycles of intravenous administration of nivolumab at a dose of 40 mg once a day 14 days. Thus, it is planned to gradually include patients in the treatment subgroups.
The frequency of complete therapeutic tumor pathomorphoses (pCR, TRG1) will be evaluated as the primary endpoint. Secondary goals are to study the safety of drug doses, to assess the frequency of pronounced therapeutic tumor pathomorphoses (MPR, TRG 1-2), to assess disease-free survival (PFS), the frequency of R0 resections, overall survival(S), and the frequency of objective response.
To study the use of low-dose immunotherapy in combination with chemotherapy in patients with metastatic dMMR/MSI CRC and gastric cancer in the first line of therapy, it is planned to use a combination of nivolumab 40 mg with FOLFOX regimen once every 14 days for 8 treatment cycles, followed by a switch to supportive intravenous monotherapy with nivolumab 40 mg.
One-year AFD will be evaluated as the primary endpoint in the group with metastatic disease. Secondary goals are to study the safety of drug doses, and to evaluate one-year DFS, OS, and CSR.
To develop methods for personalizing low-dose IT, it is planned to compare the number of PD-1-positive cells before treatment and during immunotherapy. It is expected to detect PD-1 blockade on the lymphocyte surface during therapy and assess its duration. The results of the study will be presented in the form of an indicator of the number of PD-1-positive cells (%) and an indicator of the protein density on the surface of positive cells (MFI - average fluorescence intensity).
Peripheral venous blood samples in an anticoagulant tube (3 ml) are planned before the start of therapy, before the second injection of anti-PDL antibodies and, if long-term immunotherapy is received, after 8 weeks. Monoclonal antibodies to CD45, CD4, CD8, CD279 (PD-1), and IgG4 will be used as reagents. The equipment is a BD FACS Canto II flow cytometer.
To analyze the features of radiological evaluation of the effectiveness of checkpoint inhibitor therapy (pseudoprogression), radiological monitoring will be performed before the start of therapy, before surgical treatment, and every 8 weeks of treatment with prolonged immunotherapy. The response to treatment will be evaluated according to the RECIST criteria in revision 1.1.
- Conditions
- Colorectal Cancer, Gastric Cancer
- Being tested
- Low-dose nivolumab, Low-dose nivolumab with/without chemotherapy, Low-dose nivolumab combined with chemotherapy
- Keywords
- colorectal cancer, gastric cancer, low-dose immunotherapy, MSI, dMMR
- Medical subject headings
- Colorectal Neoplasms, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dose nivolumabDrug
nivolumab 40 mg
Low-dose nivolumab with/without chemotherapyDrug
Subgroup A - 6 cycles of IV CT FOLFOX + nivolumab 40 mg once every 14 days; Subgroup B - 2 cycles of IV of nivolumab 40 mg once every 14 days; Subgroup C - 6 cycles of of nivolumab 40 mg once a day 14 days.
Low-dose nivolumab combined with chemotherapyDrug
Metastatic dMMR/MSI CRC and gastric cancer in the first line - the use of low-dose immunotherapy in combination with chemotherapy (nivolumab 40 mg + FOLFOX regimen once every 14 days for 8 cycles + maintenance monotherapy nivolumab 40 mg)
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1. dMMR/MSI locally advanced CRC | Experimental | Efficacy of low-dose immunotherapy (IT) nivolumab 40 mg for either 2 courses of therapy or 6 courses as preoperative therapy. Parallel recruitment of patients into patient subgroups by randomization. Receives: Drug: Low-dose nivolumab |
| Cohort 2. dMMR/MSI locally advanced gastric cancer | Experimental | Subgroup A includes 6 cycles of IV CT FOLFOX + nivolumab 40 mg once every 14 days; subgroup B - 2 cycles of intravenous administration of nivolumab 40 mg once every 14 days; subgroup C - 6 cycles of of nivolumab 40 mg once a day 14 days.
It is planned to gradually include patients in the subgroups. Receives: Drug: Low-dose nivolumab with/without chemotherapy |
| Cohort 3. Metastatic dMMR/MSI CRC and gastric cancer in the first line | Experimental | The use of low-dose immunotherapy in combination with chemotherapy (nivolumab 40 mg + FOLFOX regimen once every 14 days for 8 cycles + maintenance monotherapy nivolumab 40 mg) Receives: Drug: Low-dose nivolumab combined with chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response (pCR) - for M0
pCR: absence of malignant cells on the specimen of colon/rectal resection in patients who were previously treated with neoadjuvant immunotherapy, TRG1 by Mandard
Measured: up to 8 months
One-year progression-free survival (PFS) - for M1
Time from initiation of treatment to the occurrence of disease progression or death.
Measured: 12 months
Secondary outcomes (5)
Major pathologic response (MPR) - for M0
Rate of pathologic response TRG 1-2
Measured: up to 8 months
Progression-free survival (PFS) - for M0
Time from initiation of treatment to the occurrence of disease progression or death.
Measured: 12 months
R0 resection rate - for M0
Rate of R0 resection indicates a microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed
Measured: up to 8 months
Overall survival (OS) - for M0 and M1
Time from initiation of treatment to death.
Measured: 12 months
Objective response rate (ORR) - for M0 and M1
percentage of patients who achieve a response, which can either be complete response (complete disappearance of lesions) or partial response (reduction in the sum of maximal tumor diameters by at least 30% or more)
Measured: up to 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start3 Jun 2025
- Primary completion30 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies 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
- Model description
- Cohort 1. dMMR/MSI for locally advanced CRC - efficacy of low-dose immunotherapy (IT) nivolumab 40 mg for either 2 courses of therapy or 6 courses as preoperative therapy. Parallel recruitment of patients into patient subgroups by randomization. Cohort 2. dMMR/MSI locally advanced gastric cancer - efficacy of low-dose immunotherapy nivolumab 40 mg with or without addition of chemotherapy (CT) in FOLFOX regimen as preoperative therapy. Subgroup A includes 6 cycles of IV CT FOLFOX + nivolumab 40 mg once every 14 days; subgroup B - 2 cycles of intravenous administration of nivolumab 40 mg once every 14 days;subgroup C - 6 cycles of of nivolumab 40 mg once a day 14 days. It is planned to gradually include patients in the subgroups. Cohort 3. Metastatic dMMR/MSI CRC and gastric cancer in the first line - the use of low-dose immunotherapy in combination with chemotherapy (nivolumab 40 mg + FOLFOX regimen once every 14 days for 8 cycles + maintenance monotherapy nivolumab 40 mg)
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Blokhin's Russian Cancer Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07542262
- Sponsor's protocol ID
- 3NIVO402025
- Acronym
- NIVO402025
- Status last verified
- Apr 2026
- First submitted
- 14 Apr 2026
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Open-lable Single-center Clinical Study of the Efficacy and Safety of Low-dose Immunotherapy in the Treatment of Patients With Metastatic and Locally Advanced Colorectal and Gastric Cancers With Microsatellite Unstable Phenotype (MSI)/Deficiency of Mismatch Repair System (dMMR)
- ClinicalTrials.gov ID
- NCT07542262
- Acronym / sponsor ID
- NIVO402025 / 3NIVO402025
- Conditions
- Colorectal Cancer, Gastric Cancer
- Keywords
- colorectal cancer, gastric cancer, low-dose immunotherapy, MSI, dMMR
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Blokhin's Russian Cancer Research CenterUniversity, hospital or other
- Study start
- 3 Jun 2025 (actual)
- Primary completion
- 30 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 21 Apr 2026 (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.
It is planned to study the effectiveness of low-dose immunotherapy (IT) nivolumab 40 mg for either 2 courses of therapy or 6 courses as preoperative therapy in patients with dMMR/MSI locally advanced CRC. Parallel recruitment into subgroups of patients by randomization is assumed.
For dMMR/MSI locally advanced gastric cancer, it is planned to study the effectiveness of low-dose immunotherapy nivolumab 40 mg with or without the addition of chemotherapy (CT) in the FOLFOX regimen as preoperative therapy.
Subgroup A includes 6 cycles of IV CT FOLFOX + IV administration of nivolumab 40 mg once every 14 days, subgroup B - 2 cycles of intravenous administration of nivolumab at a dose of 40 mg once every 14 days, and subgroup C - 6 cycles of intravenous administration of nivolumab at a dose of 40 mg once a day 14 days. Thus, it is planned to gradually include patients in the treatment subgroups.
The frequency of complete therapeutic tumor pathomorphoses (pCR, TRG1) will be evaluated as the primary endpoint. Secondary goals are to study the safety of drug doses, to assess the frequency of pronounced therapeutic tumor pathomorphoses (MPR, TRG 1-2), to assess disease-free survival (PFS), the frequency of R0 resections, overall survival(S), and the frequency of objective response.
To study the use of low-dose immunotherapy in combination with chemotherapy in patients with metastatic dMMR/MSI CRC and gastric cancer in the first line of therapy, it is planned to use a combination of nivolumab 40 mg with FOLFOX regimen once every 14 days for 8 treatment cycles, followed by a switch to supportive intravenous monotherapy with nivolumab 40 mg.
Detailed description
It is planned to study the effectiveness of low-dose immunotherapy (IT) nivolumab 40 mg for either 2 courses of therapy or 6 courses as preoperative therapy in patients with dMMR/MSI locally advanced CRC. Parallel recruitment into subgroups of patients by randomization is assumed.
For dMMR/MSI locally advanced gastric cancer, it is planned to study the effectiveness of low-dose immunotherapy nivolumab 40 mg with or without the addition of chemotherapy (CT) in the FOLFOX regimen as preoperative therapy.
Subgroup A includes 6 cycles of IV CT FOLFOX + IV administration of nivolumab 40 mg once every 14 days, subgroup B - 2 cycles of intravenous administration of nivolumab at a dose of 40 mg once every 14 days, and subgroup C - 6 cycles of intravenous administration of nivolumab at a dose of 40 mg once a day 14 days. Thus, it is planned to gradually include patients in the treatment subgroups.
The frequency of complete therapeutic tumor pathomorphoses (pCR, TRG1) will be evaluated as the primary endpoint. Secondary goals are to study the safety of drug doses, to assess the frequency of pronounced therapeutic tumor pathomorphoses (MPR, TRG 1-2), to assess disease-free survival (PFS), the frequency of R0 resections, overall survival(S), and the frequency of objective response.
To study the use of low-dose immunotherapy in combination with chemotherapy in patients with metastatic dMMR/MSI CRC and gastric cancer in the first line of therapy, it is planned to use a combination of nivolumab 40 mg with FOLFOX regimen once every 14 days for 8 treatment cycles, followed by a switch to supportive intravenous monotherapy with nivolumab 40 mg.
One-year AFD will be evaluated as the primary endpoint in the group with metastatic disease. Secondary goals are to study the safety of drug doses, and to evaluate one-year DFS, OS, and CSR.
To develop methods for personalizing low-dose IT, it is planned to compare the number of PD-1-positive cells before treatment and during immunotherapy. It is expected to detect PD-1 blockade on the lymphocyte surface during therapy and assess its duration. The results of the study will be presented in the form of an indicator of the number of PD-1-positive cells (%) and an indicator of the protein density on the surface of positive cells (MFI - average fluorescence intensity).
Peripheral venous blood samples in an anticoagulant tube (3 ml) are planned before the start of therapy, before the second injection of anti-PDL antibodies and, if long-term immunotherapy is received, after 8 weeks. Monoclonal antibodies to CD45, CD4, CD8, CD279 (PD-1), and IgG4 will be used as reagents. The equipment is a BD FACS Canto II flow cytometer.
To analyze the features of radiological evaluation of the effectiveness of checkpoint inhibitor therapy (pseudoprogression), radiological monitoring will be performed before the start of therapy, before surgical treatment, and every 8 weeks of treatment with prolonged immunotherapy. The response to treatment will be evaluated according to the RECIST criteria in revision 1.1.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Cohort 1. dMMR/MSI for locally advanced CRC - efficacy of low-dose immunotherapy (IT) nivolumab 40 mg for either 2 courses of therapy or 6 courses as preoperative therapy. Parallel recruitment of patients into patient subgroups by randomization. Cohort 2. dMMR/MSI locally advanced gastric cancer - efficacy of low-dose immunotherapy nivolumab 40 mg with or without addition of chemotherapy (CT) in FOLFOX regimen as preoperative therapy. Subgroup A includes 6 cycles of IV CT FOLFOX + nivolumab 40 mg once every 14 days; subgroup B - 2 cycles of intravenous administration of nivolumab 40 mg once every 14 days;subgroup C - 6 cycles of of nivolumab 40 mg once a day 14 days. It is planned to gradually include patients in the subgroups. Cohort 3. Metastatic dMMR/MSI CRC and gastric cancer in the first line - the use of low-dose immunotherapy in combination with chemotherapy (nivolumab 40 mg + FOLFOX regimen once every 14 days for 8 cycles + maintenance monotherapy nivolumab 40 mg)
| Arm | Type | Receives |
|---|---|---|
| Cohort 1. dMMR/MSI locally advanced CRC | Experimental | Drug: Low-dose nivolumabEfficacy of low-dose immunotherapy (IT) nivolumab 40 mg for either 2 courses of therapy or 6 courses as preoperative therapy. Parallel recruitment of patients into patient subgroups by randomization. |
| Cohort 2. dMMR/MSI locally advanced gastric cancer | Experimental | Drug: Low-dose nivolumab with/without chemotherapySubgroup A includes 6 cycles of IV CT FOLFOX + nivolumab 40 mg once every 14 days; subgroup B - 2 cycles of intravenous administration of nivolumab 40 mg once every 14 days; subgroup C - 6 cycles of of nivolumab 40 mg once a day 14 days. It is planned to gradually include patients in the subgroups. |
| Cohort 3. Metastatic dMMR/MSI CRC and gastric cancer in the first line | Experimental | Drug: Low-dose nivolumab combined with chemotherapyThe use of low-dose immunotherapy in combination with chemotherapy (nivolumab 40 mg + FOLFOX regimen once every 14 days for 8 cycles + maintenance monotherapy nivolumab 40 mg) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Availability of voluntarily signed informed consent from the patient;
- Men and women, 18 years old </=;
- Histologically confirmed adenocarcinoma of the colon/rectum/stomach;
- Presence of MSI/dMMR in the tumor;
- For M0-cohort: locally advanced tumor - cT3-4N0-2M0 according to CT for tumors of the colon and sigmoid colon; cT3 with a depth of tissue invasion ≥5mm (cT2N0 and higher for lower ampullary cancer) or T4 or involvement of the lateral resection margins according to MRI for rectal cancer; for gastric cancer: cT2</=, N0-3, no presence of tumour cells in peritoneum (cyt-);
Key exclusion criteria (18 listed)
- Previous therapy with the inclusion of monoclonal antibodies - anti-PD1, anti-PD-L1, anti PD-L2, anti-CTLA4 antibodies and other immunotherapy drugs
- The presence of any other malignant tumor, with the exception of radically treated basal cell carcinoma, cervical cancer in situ, currently or within 5 years before inclusion in the study
- Pregnant and lactating women, as well as planning pregnancy during the period of therapy in a clinical trial and 6 months after the end of therapy
- Patients with preserved reproductive potential who refuse to use adequate methods of contraception throughout the study and 6 months after the end of therapy or who agree to abstain from heterosexual contact.
- Previous systemic therapy with immunosuppressive drugs (including, but not limited to: prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide and TNF [tumor necrosis factor] antagonists) within 4 weeks before signing the informed consent form, or the need to use immunosuppressive therapy in during the first year of the study.
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 |
|---|---|---|
| Low-dose nivolumabnivolumab 40 mg | Drug | Cohort 1. dMMR/MSI locally advanced CRC |
| Low-dose nivolumab with/without chemotherapySubgroup A - 6 cycles of IV CT FOLFOX + nivolumab 40 mg once every 14 days; Subgroup B - 2 cycles of IV of nivolumab 40 mg once every 14 days; Subgroup C - 6 cycles of of nivolumab 40 mg once a day 14 days. | Drug | Cohort 2. dMMR/MSI locally advanced gastric cancer |
| Low-dose nivolumab combined with chemotherapyMetastatic dMMR/MSI CRC and gastric cancer in the first line - the use of low-dose immunotherapy in combination with chemotherapy (nivolumab 40 mg + FOLFOX regimen once every 14 days for 8 cycles + maintenance monotherapy nivolumab 40 mg) | Drug | Cohort 3. Metastatic dMMR/MSI CRC and gastric cancer in the first line |
Primary outcome
Pathological complete response (pCR) - for M0
Time frame: up to 8 months
pCR: absence of malignant cells on the specimen of colon/rectal resection in patients who were previously treated with neoadjuvant immunotherapy, TRG1 by Mandard
One-year progression-free survival (PFS) - for M1
Time frame: 12 months
Time from initiation of treatment to the occurrence of disease progression or death.
5 secondary outcomes
Major pathologic response (MPR) - for M0
Time frame: up to 8 months
Progression-free survival (PFS) - for M0
Time frame: 12 months
R0 resection rate - for M0
Time frame: up to 8 months
Overall survival (OS) - for M0 and M1
Time frame: 12 months
Objective response rate (ORR) - for M0 and M1
Time frame: up to 8 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Low-dose nivolumab, Low-dose nivolumab with/without chemotherapy and Low-dose nivolumab combined with chemotherapy in people with Colorectal Cancer and Gastric Cancer, run by Blokhin's Russian Cancer Research Center at 1 site in Russia.
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 8 inclusion and 18 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: enrolling by invitation, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. 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?
This study is still under way. Results are not available in the source record yet.
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?
Pathological complete response (pCR) - for M0 (time frame: up to 8 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 24 Apr 2026.