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Patients with clinical stage II-III dMMR/MSI colorectal adenocarcinoma will be treated with low-dose immunotherapy: nivolumab 100 mg or pembrolizumab 100 mg. The duration of treatment is 6 months.
Patients with clinical high risk stage II (T3 with extramural extension ≥ 5mm or T4), stage III dMMR/MSI CRC will be treated with low-dose immunotherapy: nivolumab 100 mg every 2 weeks or pembrolizumab 100 mg every 4 weeks, then will be underwent surgery after 6 months of immunotherapy. Pts who refuse surgery and/or in case of complete clinical response (cCR) will continue therapy up to 1 year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nivolumab | Experimental | The patients will be treated with nivolumab 100 mg every 2 weeks during 6 months until surgery |
|
| Pembrolizumab | Experimental | The patients will be treated with pembrolizumab 100 mg every 4 weeks during 6 months until surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab | Drug | Nivolumab 100 mg infusion |
| |
| Pembrolizumab |
| Measure | Description | Time Frame |
|---|---|---|
| Complete response (pathological complete response - pCR + durable clinical complete response - cCR) | pCR: absence of malignant cells on the specimen of colon/rectal resection in patients who were previously treated with neoadjuvant immunotherapy cCR: absence of detectable tumor via endoscopy and MRI up to 6 months | up to 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Durable complete clinical response rate (DRR) | A continuous response [complete or partial objective response] beginning within 6 months of treatment and lasting ≥6 months | up to 12 months |
| Progression-free survival (PFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| N.N. Blokhin NMRCO | Moscow | Russia |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| C582435 | pembrolizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Drug |
Pembrolizumab 100 mg infusion |
|
Time from initiation of treatment to the occurrence of disease progression or death.
| 12 months |
| Overall survival (OS) | Time from initiation of treatment to death. | 12 months |
| Objective response rate (ORR) | 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) | up to 8 months |
| Major pathologic response (MPR) | Rate of pathologic response TRG 1-2 | up to 8 months |
| Incidence of Treatment-Related Adverse Events as assessed by investigator | Incidence of Adverse Events assessed according to CTCAE version 5 | up to 6 months |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |