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| Name | Class |
|---|---|
| Agenus Inc. | INDUSTRY |
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This is a pilot study to see whether a combination of two investigational drugs that target the immune system can be given to people with colorectal cancer before surgically removing the tumor. This study is also being done to see what side effects this combination of drugs has and what effect they have on colorectal cancer. The two monoclonal antibodies are balstilimab, a programmed cell death protein 1 (PD-1) inhibitor, and botensilimab, a cytotoxic T lymphocyte-associated protein 4 (CTLA-4) inhibitor. This study has 3 cohorts. Participants in Cohort A will receive a total of 2 doses of balstilimab and a single dose of botensilimab, both given intravenously (IV), before surgery. Participants in Cohort B and C will receive a total of 4 doses of balstilimab and a single dose of botensilimab, both given intravenously (IV), before surgery. Participants in Cohort C must have dMMR/MSI-High colorectal cancer.
This is a pilot study to assess the feasibility, safety, and efficacy of using a combination of a programmed cell death protein 1 (PD-1) inhibitor (balstilimab) and cytotoxic T lymphocyte-associated protein 4 (CTLA-4) inhibitor (botensilimab) in the neoadjuvant setting in patients with colorectal cancer, prior to resection. This is a single-center, open-label, pilot study in which patients will receive 2 or 4 doses of intravenous (IV) balstilimab (each dose approximately 2 weeks apart), and a single dose of botensilimab IV, prior to resection in patients with colon cancer. Following surgical resection, participants will return to the clinic for 1-2 post-op follow-up visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A: Botensilimab and balstilimab (bot/bal) | Experimental | Botensilimab and balstilimab are both monoclonal antibodies that are administered intravenously. Two doses of balstilimab (240 mg IV), will be administered approximately 2 weeks apart. A single dose of botensilimab (75 mg IV) will be administered on the same day as the first dose of balstilimab. Surgical resection will occur 1-6 weeks following the second dose of balstilimab. |
|
| Cohort B: | Experimental | Botensilimab and balstilimab are both monoclonal antibodies that are administered intravenously. Four doses of balstilimab (240 mg IV), will be administered approximately 2 weeks apart. A single dose of botensilimab (75 mg IV) will be administered on the same day as the first dose of balstilimab. Surgical resection will occur 1-6 weeks following the fourth dose of balstilimab. |
|
| Cohort C: | Experimental | Botensilimab and balstilimab are both monoclonal antibodies that are administered intravenously. Four doses of balstilimab (240 mg IV), will be administered approximately 2 weeks apart. A single dose of botensilimab (75 mg IV) will be administered on the same day as the first dose of balstilimab. Surgical resection will occur 1-6 weeks following the fourth dose of balstilimab. Cohort C only includes patients with dMMR/MSI-High colorectal cancer. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botensilimab | Drug | Botensilimab, a CTLA-4 inhibitor, will be administered prior to surgical resection as described in the arm description. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cohort A and B: Pathological Overall Response (pOR) Rate Determined by Analysis of Tissue Resected During Surgery Reported by Cohort | Resected tumors will be examined in their entirety, and regression of resected tumors was assessed by estimating the percentage of residual viable tumor of the macroscopically identifiable tumor bed, as identified on routine hematoxylin and eosin (H&E) staining. In addition, regression will be classified using the Mandard tumor regression grading system. Major pathologic response (MPR) will be defined as ≤10% of residual viable tumor cells (or ≥ 90% response), corresponding to Mandard tumor regression grade 1 (CR) or 2 (near-CR). PR will be defined as at least 50% tumor regression. However, considering the lack of consensus on the definition of PR after immunotherapy, tumors with >50% and <90% residual viable tumor will be labeled accordingly as '10-50% tumor regression', as per the NICHE study (Chalabi et. al., 2020). When analyzing pMMR responders versus pMMR nonresponders, this subgroup will be included in the group of nonresponders. | Immediately following surgical resection of the primary tumor |
| Cohort A: Number of Participants Who Experience Potentially Treatment-related SAEs According to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 at 90 Days Following the Last Treatment With Balstilimab or Botensilimab | Safety will be assessed by evaluation of the number of participants experiencing SAEs according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 at 90 days post-the last dose of study drug. Grade 3 or 4 adverse event possibly, probably or definitely attributed to bot/bal. Patients from cohorts B and C were not included in the analysis of this outcome measure per study protocol. | From date of last dose of study drug up to 90 days after |
| Cohort A: Number of Participants Who Experience Treatment-related Complications Leading to Delays of 12 Weeks or More in Surgery After Treatment Initiation (Day 0) | Any AEs or SAEs that lead to a delay in surgery greater than 12 weeks from treatment initiation (Day 0) will be recorded. If there are ≥ 2 patients out of the first 6 patients, or ≥ 4 patients out of the full 12 participants (≥33%), with AEs/SAEs that lead to a delay in surgery beyond 12 weeks from treatment initiation, with the exception of COVID-related procedural delays, then this combination of botensilimab and balstilimab, at these dosages will not be considered feasible in this population. |
| Measure | Description | Time Frame |
|---|---|---|
| All Cohorts: Changes in Minimal Residual Disease Assessed Using ctDNA Pre- and 30 Days Post-surgical Resection | Summary statistics including mean, standard deviation will be provided for ctDNA levels obtained at various time points. Linear mixed-effects models will be used to model longitudinal biomarker values. Simultaneous testing of general linear hypotheses will be used to evaluate contrasts of interest. |
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Inclusion Criteria:
Exclusion Criteria:
Participants in Cohort C must be dMMR/MSI-High.
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| Name | Affiliation | Role |
|---|---|---|
| Manish Shah, M.D. | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medicine/New York-Presbyterian Brooklyn Methodist Hospital | Brooklyn | New York | 11215 | United States | ||
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort A: Botensilimab and Balstilimab (Bot/Bal) | Botensilimab and balstilimab are both monoclonal antibodies that are administered intravenously. Two doses of balstilimab (240 mg IV), will be administered approximately 2 weeks apart. A single dose of botensilimab (75 mg IV) will be administered on the same day as the first dose of balstilimab. Surgical resection will occur 1-6 weeks following the second dose of balstilimab. Botensilimab: Botensilimab, a CTLA-4 inhibitor, will be administered prior to surgical resection as described in the arm description. Balstilimab: Balstilimab, a PD-1 inhibitor, will be administered prior to surgical resection as described in the arm description. |
| FG001 | Cohort B: | Botensilimab and balstilimab are both monoclonal antibodies that are administered intravenously. Four doses of balstilimab (240 mg IV), will be administered approximately 2 weeks apart. A single dose of botensilimab (75 mg IV) will be administered on the same day as the first dose of balstilimab. Surgical resection will occur 1-6 weeks following the fourth dose of balstilimab. Botensilimab: Botensilimab, a CTLA-4 inhibitor, will be administered prior to surgical resection as described in the arm description. Balstilimab: Balstilimab, a PD-1 inhibitor, will be administered prior to surgical resection as described in the arm description. |
| FG002 | Cohort C: | Botensilimab and balstilimab are both monoclonal antibodies that are administered intravenously. Four doses of balstilimab (240 mg IV), will be administered approximately 2 weeks apart. A single dose of botensilimab (75 mg IV) will be administered on the same day as the first dose of balstilimab. Surgical resection will occur 1-6 weeks following the fourth dose of balstilimab. Cohort C only includes patients with dMMR/MSI-High colorectal cancer. Botensilimab: Botensilimab, a CTLA-4 inhibitor, will be administered prior to surgical resection as described in the arm description. Balstilimab: Balstilimab, a PD-1 inhibitor, will be administered prior to surgical resection as described in the arm description. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
2 patients in cohort A were found to be ineligible due to identification of metastatic disease or incomplete resection.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort A: Botensilimab and Balstilimab (Bot/Bal) | Botensilimab and balstilimab are both monoclonal antibodies that are administered intravenously. Two doses of balstilimab (240 mg IV), will be administered approximately 2 weeks apart. A single dose of botensilimab (75 mg IV) will be administered on the same day as the first dose of balstilimab. Surgical resection will occur 1-6 weeks following the second dose of balstilimab. Botensilimab: Botensilimab, a CTLA-4 inhibitor, will be administered prior to surgical resection as described in the arm description. Balstilimab: Balstilimab, a PD-1 inhibitor, will be administered prior to surgical resection as described in the arm description. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cohort A and B: Pathological Overall Response (pOR) Rate Determined by Analysis of Tissue Resected During Surgery Reported by Cohort | Resected tumors will be examined in their entirety, and regression of resected tumors was assessed by estimating the percentage of residual viable tumor of the macroscopically identifiable tumor bed, as identified on routine hematoxylin and eosin (H&E) staining. In addition, regression will be classified using the Mandard tumor regression grading system. Major pathologic response (MPR) will be defined as ≤10% of residual viable tumor cells (or ≥ 90% response), corresponding to Mandard tumor regression grade 1 (CR) or 2 (near-CR). PR will be defined as at least 50% tumor regression. However, considering the lack of consensus on the definition of PR after immunotherapy, tumors with >50% and <90% residual viable tumor will be labeled accordingly as '10-50% tumor regression', as per the NICHE study (Chalabi et. al., 2020). When analyzing pMMR responders versus pMMR nonresponders, this subgroup will be included in the group of nonresponders. | The analysis population includes all eligible enrolled patients who met protocol-defined criteria and were evaluable for the primary outcome. Two enrolled subjects were excluded from the primary analysis: one subject was determined to be ineligible due to incomplete tumor resection, and one subject was determined to be ineligible after enrollment following identification of metastatic disease. Patients from cohort C were not included in the analysis of this outcome measure per study protocol. | Posted | Count of Participants | Participants |
Adverse events following initiation of therapy up to 90 days from last treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort A: Botensilimab and Balstilimab (Bot/Bal) | Botensilimab and balstilimab are both monoclonal antibodies that are administered intravenously. Two doses of balstilimab (240 mg IV), will be administered approximately 2 weeks apart. A single dose of botensilimab (75 mg IV) will be administered on the same day as the first dose of balstilimab. Surgical resection will occur 1-6 weeks following the second dose of balstilimab. Botensilimab: Botensilimab, a CTLA-4 inhibitor, will be administered prior to surgical resection as described in the arm description. Balstilimab: Balstilimab, a PD-1 inhibitor, will be administered prior to surgical resection as described in the arm description. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Distension | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Casey Owens | Weill Cornell Medicine | 6469626200 | cdo4001@med.cornell.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 10, 2026 | Mar 27, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| C563326 | Diabetes Mellitus, Insulin-Dependent, 12 |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C000720935 | balstilimab |
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| Balstilimab | Drug | Balstilimab, a PD-1 inhibitor, will be administered prior to surgical resection as described in the arm description. |
|
| 12 weeks after treatment initiation date (Day 0) |
| Cohort C: Composite Rate of Clinical Complete Response or Major Pathological Response at 6 Months | The joint patient-surgeon decision to defer surgery for a watch and wait (Watch-&-Wait W&W) approach is allowed as long as the patient is demonstrating sustained response as determined by clinical, radiographic, endoscopic, and/or blood-based biomarkers. For participants who elect to undergo surgery, pathological response will be determined as described above. The key endpoint here will be "Major pathological response (MPR; CR + near-CR). Patients who opt for non-operative management based on clinical response will be considered to have CR. Complete response will be determined by the treating physician and surgeon based on composite subjective and objective assessments of clinical, radiographic, endoscopic, blood-based biomarker assessments, and/or the absence of clinical and radiographic progression. | 6 months |
| Immediately prior to initiation of therapy and 30 days following surgical resection |
| All Cohorts: Changes in Minimal Residual Disease Assessed Using ctDNA Pre- and 30 Days Post-surgical Resection | Median and range will be provided for ctDNA levels obtained at various time points. Linear mixed-effects models will be used to model longitudinal biomarker values. Simultaneous testing of general linear hypotheses will be used to evaluate contrasts of interest. | Immediately prior to initiation of therapy and 30 days following surgical resection |
| Weill Cornell Medicine/NewYork Presbyterian - Queens |
| Flushing |
| New York |
| 11355 |
| United States |
| Weill Cornell Medicine/NewYork-Presbyterian Hospital | New York | New York | 10021 | United States |
| Subject has pending visit |
|
| BG001 | Cohort B: | Botensilimab and balstilimab are both monoclonal antibodies that are administered intravenously. Four doses of balstilimab (240 mg IV), will be administered approximately 2 weeks apart. A single dose of botensilimab (75 mg IV) will be administered on the same day as the first dose of balstilimab. Surgical resection will occur 1-6 weeks following the fourth dose of balstilimab. Botensilimab: Botensilimab, a CTLA-4 inhibitor, will be administered prior to surgical resection as described in the arm description. Balstilimab: Balstilimab, a PD-1 inhibitor, will be administered prior to surgical resection as described in the arm description. |
| BG002 | Cohort C: | Botensilimab and balstilimab are both monoclonal antibodies that are administered intravenously. Four doses of balstilimab (240 mg IV), will be administered approximately 2 weeks apart. A single dose of botensilimab (75 mg IV) will be administered on the same day as the first dose of balstilimab. Surgical resection will occur 1-6 weeks following the fourth dose of balstilimab. Cohort C only includes patients with dMMR/MSI-High colorectal cancer. Botensilimab: Botensilimab, a CTLA-4 inhibitor, will be administered prior to surgical resection as described in the arm description. Balstilimab: Balstilimab, a PD-1 inhibitor, will be administered prior to surgical resection as described in the arm description. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Colon Cancer Type: | Count of Participants | Participants |
|
| pMMR | Count of Participants | Participants |
|
| Immediately following surgical resection of the primary tumor |
|
|
|
| Primary | Cohort A: Number of Participants Who Experience Potentially Treatment-related SAEs According to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 at 90 Days Following the Last Treatment With Balstilimab or Botensilimab | Safety will be assessed by evaluation of the number of participants experiencing SAEs according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 at 90 days post-the last dose of study drug. Grade 3 or 4 adverse event possibly, probably or definitely attributed to bot/bal. Patients from cohorts B and C were not included in the analysis of this outcome measure per study protocol. | The analysis population includes all eligible enrolled patients who met protocol-defined criteria and were evaluable for the primary outcome. Two enrolled subjects were excluded from the primary analysis: one subject was determined to be ineligible due to incomplete tumor resection, and one subject was determined to be ineligible after enrollment following identification of metastatic disease. Cohorts B and C were not included in the data analysis for this primary outcome per protocol. | Posted | Count of Participants | Participants | From date of last dose of study drug up to 90 days after |
|
|
|
| Primary | Cohort A: Number of Participants Who Experience Treatment-related Complications Leading to Delays of 12 Weeks or More in Surgery After Treatment Initiation (Day 0) | Any AEs or SAEs that lead to a delay in surgery greater than 12 weeks from treatment initiation (Day 0) will be recorded. If there are ≥ 2 patients out of the first 6 patients, or ≥ 4 patients out of the full 12 participants (≥33%), with AEs/SAEs that lead to a delay in surgery beyond 12 weeks from treatment initiation, with the exception of COVID-related procedural delays, then this combination of botensilimab and balstilimab, at these dosages will not be considered feasible in this population. | This is not appliable for cohorts B and C per the specified study reporting. The analysis population includes all eligible enrolled patients who met protocol-defined criteria and were evaluable for the primary outcome. Two enrolled subjects were excluded from the primary analysis: one subject was determined to be ineligible due to incomplete tumor resection, and one subject was determined to be ineligible after enrollment following identification of metastatic disease. | Posted | Count of Participants | Participants | 12 weeks after treatment initiation date (Day 0) |
|
|
|
| Primary | Cohort C: Composite Rate of Clinical Complete Response or Major Pathological Response at 6 Months | The joint patient-surgeon decision to defer surgery for a watch and wait (Watch-&-Wait W&W) approach is allowed as long as the patient is demonstrating sustained response as determined by clinical, radiographic, endoscopic, and/or blood-based biomarkers. For participants who elect to undergo surgery, pathological response will be determined as described above. The key endpoint here will be "Major pathological response (MPR; CR + near-CR). Patients who opt for non-operative management based on clinical response will be considered to have CR. Complete response will be determined by the treating physician and surgeon based on composite subjective and objective assessments of clinical, radiographic, endoscopic, blood-based biomarker assessments, and/or the absence of clinical and radiographic progression. | This outcome measure is not applicable to cohorts A and B per the study protocol. | Posted | Number | percentage of patients | 6 months |
|
|
|
| Secondary | All Cohorts: Changes in Minimal Residual Disease Assessed Using ctDNA Pre- and 30 Days Post-surgical Resection | Summary statistics including mean, standard deviation will be provided for ctDNA levels obtained at various time points. Linear mixed-effects models will be used to model longitudinal biomarker values. Simultaneous testing of general linear hypotheses will be used to evaluate contrasts of interest. | The analysis population includes patients who had ctDNA collected at baseline prior to initiation of therapy. Per protocol, ctDNA collection was optional. Patients without baseline ctDNA collection were not included in this analysis. | Posted | Mean | Standard Deviation | MTM/ml | Immediately prior to initiation of therapy and 30 days following surgical resection |
|
|
|
| Secondary | All Cohorts: Changes in Minimal Residual Disease Assessed Using ctDNA Pre- and 30 Days Post-surgical Resection | Median and range will be provided for ctDNA levels obtained at various time points. Linear mixed-effects models will be used to model longitudinal biomarker values. Simultaneous testing of general linear hypotheses will be used to evaluate contrasts of interest. | The analysis population includes patients who had ctDNA collected at baseline prior to initiation of therapy. Per protocol, ctDNA collection was optional. Patients without baseline ctDNA collection were not included in this analysis. | Posted | Median | Full Range | MTM/ml | Immediately prior to initiation of therapy and 30 days following surgical resection |
|
|
|
| 0 |
| 12 |
| 3 |
| 12 |
| 4 |
| 12 |
| EG001 | Cohort B: | Botensilimab and balstilimab are both monoclonal antibodies that are administered intravenously. Four doses of balstilimab (240 mg IV), will be administered approximately 2 weeks apart. A single dose of botensilimab (75 mg IV) will be administered on the same day as the first dose of balstilimab. Surgical resection will occur 1-6 weeks following the fourth dose of balstilimab. Botensilimab: Botensilimab, a CTLA-4 inhibitor, will be administered prior to surgical resection as described in the arm description. Balstilimab: Balstilimab, a PD-1 inhibitor, will be administered prior to surgical resection as described in the arm description. | 0 | 13 | 5 | 13 | 10 | 13 |
| EG002 | Cohort C: | Botensilimab and balstilimab are both monoclonal antibodies that are administered intravenously. Four doses of balstilimab (240 mg IV), will be administered approximately 2 weeks apart. A single dose of botensilimab (75 mg IV) will be administered on the same day as the first dose of balstilimab. Surgical resection will occur 1-6 weeks following the fourth dose of balstilimab. Cohort C only includes patients with dMMR/MSI-High colorectal cancer. Botensilimab: Botensilimab, a CTLA-4 inhibitor, will be administered prior to surgical resection as described in the arm description. Balstilimab: Balstilimab, a PD-1 inhibitor, will be administered prior to surgical resection as described in the arm description. | 0 | 1 | 0 | 1 | 1 | 1 |
| Atrial Fibrillation | Cardiac disorders | CTCAE (5.0) | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
|
| Edema in Limbs | General disorders | CTCAE (5.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (5.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | CTCAE (5.0) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
|
| Edema in limbs | General disorders | CTCAE (5.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (5.0) | Systematic Assessment |
|
| Pyrexia | General disorders | CTCAE (5.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
|
| Myositis | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Pain | General disorders | CTCAE (5.0) | Systematic Assessment |
|
| Skin Infection | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
|
| Pharyngitis | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Chills | General disorders | CTCAE (5.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
|
| Vomitting | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| 30 Days Post Resection |
|
|