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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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This study evaluated the safety and efficacy of VE800 in combination with nivolumab in patients with selected types of advanced or metastatic cancer
CONSORTIUM-IO was the first-in-human multicenter, open-label study; the main objectives were to evaluate:
The study planned to enroll approximately 111 patients with melanoma, gastric/gastroesophageal junction (GEJ) adenocarcinoma, or microsatellite-stable (MSS) colorectal cancer (CRC).
Nivolumab is already approved by the U.S. Food and Drug Administration (FDA), however, it is not approved for the study cancer indications. VE800 was the investigational product, which was designed to enhance the immune response to the tumor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VE800 combination treatment with nivolumab | Experimental | Subjects received 5 days of oral vancomycin, followed by daily VE800 in combination with nivolumab every 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VE800 | Biological | VE800 is an orally administered (PO) live biotherapeutic product (LBP) consisting of 11 distinct nonpathogenic, nontoxigenic, commensal bacterial strains manufactured under Good Manufacturing Practice (GMP) conditions. These strains were selected for their ability to induce an immune response. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Safety and tolerability of VE800 in combination with nivolumab: Number of Participants with Adverse Events | From the first dose to the last dose (up to 56.7 weeks), plus 100 days of post-treatment follow-up |
| Objective Response Rate (ORR) | Objective Response Rate (ORR) Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. | 18 months (first patient enrolled to last patient visit completed) |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response (DOR) | Defined as the time from first documentation of complete response (CR) or partial response (PR) until the time of first documentation of progressive disease (PD) according to RECIST 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. |
Not provided
Partial Inclusion Criteria:
Partial Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Judy Wang, MD | SCRI - Florida Cancer Specialists - Sarasota Cattlemen Office (Coordinating Investigator) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HonorHealth Research Institute | Scottsdale | Arizona | 85258 | United States | ||
| University of California Los Angeles |
Not provided
Not provided
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Up to 111 evaluable patients were to be enrolled: 42 patients with melanoma, 42 patients with gastric/gastroesophageal junction (GEJ) adenocarcinoma, and 27 patients with CRC-MSS.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | VE800 combination treatment with nivolumab | Subjects received 5 days of oral vancomycin, followed by daily VE800 in combination with nivolumab every 4 weeks. VE800: VE800 is a PO LBP consisting of 11 distinct nonpathogenic, nontoxigenic, commensal bacterial strains manufactured under GMP conditions. These strains were selected for their ability to induce an immune response. Nivolumab: Nivolumab is an approved medication that blocks antibodies for certain types of cancer. Vancomycin Oral Capsule: Vancomycin is an antibiotic used to treat or prevent infection. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 11, 2019 | Oct 13, 2022 |
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This study was designed to help determine the safety and effectiveness of the study drug, VE800, in combination with nivolumab in patients with advanced/metastatic cancer.
The following cohorts of patients with advanced/metastatic cancer were enrolled:
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|
| Nivolumab | Drug | Nivolumab is an approved medication that blocks antibodies for certain types of cancer. |
|
|
| Vancomycin Oral Capsule | Drug | Vancomycin is an antibiotic used to treat or prevent infection. |
|
|
| Up to two years |
| Best Overall Response | Best response among all overall responses from cycle 1 day 1 (C1D1) until disease progression or start of new anticancer therapy. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. | Up to 2 years |
| Disease Control Rate (DCR) | The percentage of patients who have achieved complete response (CR), partial response (PR), or stable disease (SD) from cycle 1 day 1 (C1D1) until disease progression (DP) or start of new anticancer therapy. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. | Up to 2 years |
| Progression-Free Survival (PFS) | Progression-Free Survival (PFS) is defined as the time from start of treatment to the earlier date of assessment of progression or death by any cause in the absence of progression. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions | From the first dose to the last dose (up to 56.7 weeks), plus 100 days of post-treatment follow-up and then follow-up for survival every 90 days. |
| Overall Survival (OS) | Overall Survival (OS) as measured from the date of start of treatment to the date of death by any cause will also be evaluated. | 18 months (first patient enrolled to last patient visit completed) |
| Detection of VE800 Bacterial Strain Colonization in Stool | Detection of VE800 bacterial strain colonization in stool was measured by pharmacokinetics (PK) of VE800 | 18 months (first patient enrolled to last patient visit completed) |
| Degree of VE800 Bacterial Strain Colonization in Stool | Measured by pharmacokinetics (PK) of VE800 colonization in stool | 18 months (first patient enrolled to last patient visit completed) |
| Duration of VE800 Bacterial Strain Colonization in Stool | Measured by pharmacokinetics (PK) of VE800 colonization in stool | 18 months (first patient enrolled to last patient visit completed) |
| Los Angeles |
| California |
| 90095 |
| United States |
| Pacific Hematology Oncology Associates | San Francisco | California | 94115 | United States |
| The Angeles Clinic and Research Institute - West Los Angeles Office | Santa Monica | California | 90404 | United States |
| University of California Los Angeles | Santa Monica | California | 90404 | United States |
| Florida Cancer Specialists | Sarasota | Florida | 34232 | United States |
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
| The University of Chicago | Chicago | Illinois | 60637 | United States |
| Indiana University Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | 46202 | United States |
| Washington University School of Medicine Siteman Cancer Center | St Louis | Missouri | 63110 | United States |
| John Theurer Cancer Center | Hackensack | New Jersey | 07601 | United States |
| New York University Medical Oncology Associates | New York | New York | 10016 | United States |
| Weill Cornell Medicine | New York | New York | 10065 | United States |
| UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | United States |
| The Miriam Hospital | Providence | Rhode Island | 02906 | United States |
| Baylor Scott and White Center for Advanced Heart and Lung Disese | Dallas | Texas | 75246 | United States |
| Huntsman Cancer Institute and Hospital | Salt Lake City | Utah | 84112 | United States |
| Swedish Medical Oncology - First Hill | Seattle | Washington | 98104 | United States |
| gastric/GEJ adenocarcinoma |
|
| Melanoma |
|
| CRC-MSS |
|
| not treated with VE800 |
|
| COMPLETED |
|
| NOT COMPLETED |
|
Excludes one subject with gastric/GEJ adenocarcinoma who discontinued before beginning pretreatment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | VE800 combination treatment with nivolumab | Subjects received 5 days of oral vancomycin, followed by daily VE800 in combination with nivolumab every 4 weeks. VE800: VE800 is a PO LBP consisting of 11 distinct nonpathogenic, nontoxigenic, commensal bacterial strains manufactured under GMP conditions. These strains were selected for their ability to induce an immune response. Nivolumab: Nivolumab is an approved medication that blocks antibodies for certain types of cancer. Vancomycin Oral Capsule: Vancomycin is an antibiotic used to treat or prevent infection. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Analyzed separately for each tumor type. | Mean | Standard Deviation | years |
| ||||||||||||||||
| Sex: Female, Male | Two of the 56 enrolled subjects did not receive VE800/nivolumab. One subject in the melanoma group received vancomycin only and is included in the baseline characteristics analysis; one subject in the gastric/GEJ adenocarcinoma group did not receive any study-related treatment and is not included in this analysis. | Count of Participants | Participants |
| |||||||||||||||||
| Race (NIH/OMB) | Two of the 56 enrolled subjects did not receive VE800/nivolumab. One subject in the melanoma group received vancomycin only and is included in the baseline characteristics analysis; one subject in the gastric/GEJ adenocarcinoma group did not receive any study-related treatment and is not included in this analysis. | Count of Participants | 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 | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Safety and tolerability of VE800 in combination with nivolumab: Number of Participants with Adverse Events | The analysis population included all subjects who received at least one dose of VE800 or nivolumab. Total number of subjects with at least 1 Treatment Emergent Adverse Event Reported | Posted | Number | participants | From the first dose to the last dose (up to 56.7 weeks), plus 100 days of post-treatment follow-up |
|
|
| |||||||||||||||||||||||||||||||||||
| Primary | Objective Response Rate (ORR) | Objective Response Rate (ORR) Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. | The analysis population included all subjects who received at least one dose of VE800 or nivolumab. | Posted | Count of Participants | Participants | 18 months (first patient enrolled to last patient visit completed) |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) | Defined as the time from first documentation of complete response (CR) or partial response (PR) until the time of first documentation of progressive disease (PD) according to RECIST 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. | The analysis population includes all subjects who received at least one dose of VE800 or nivolumab and had an objective response. | Posted | Number | months | Up to two years |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Best Overall Response | Best response among all overall responses from cycle 1 day 1 (C1D1) until disease progression or start of new anticancer therapy. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. | The analysis population included all subjects who received at least one dose of VE800 or nivolumab. | Posted | Count of Participants | Participants | Up to 2 years |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Disease Control Rate (DCR) | The percentage of patients who have achieved complete response (CR), partial response (PR), or stable disease (SD) from cycle 1 day 1 (C1D1) until disease progression (DP) or start of new anticancer therapy. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. | The analysis population included all subjects who received at least one dose of VE800 or nivolumab. | Posted | Count of Participants | Participants | Up to 2 years |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Progression-Free Survival (PFS) | Progression-Free Survival (PFS) is defined as the time from start of treatment to the earlier date of assessment of progression or death by any cause in the absence of progression. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions | The analysis population included all subjects who received at least one dose of VE800 or nivolumab. | Posted | Median | 90% Confidence Interval | months | From the first dose to the last dose (up to 56.7 weeks), plus 100 days of post-treatment follow-up and then follow-up for survival every 90 days. |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | Overall Survival (OS) as measured from the date of start of treatment to the date of death by any cause will also be evaluated. | The analysis population included all subjects who received at least one dose of VE800 or nivolumab. | Posted | Median | 90% Confidence Interval | months | 18 months (first patient enrolled to last patient visit completed) |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Detection of VE800 Bacterial Strain Colonization in Stool | Detection of VE800 bacterial strain colonization in stool was measured by pharmacokinetics (PK) of VE800 | Not Posted | 18 months (first patient enrolled to last patient visit completed) | Participants | ||||||||||||||||||||||||||||||||||||||||
| Secondary | Degree of VE800 Bacterial Strain Colonization in Stool | Measured by pharmacokinetics (PK) of VE800 colonization in stool | Not Posted | 18 months (first patient enrolled to last patient visit completed) | Participants | ||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of VE800 Bacterial Strain Colonization in Stool | Measured by pharmacokinetics (PK) of VE800 colonization in stool | Not Posted | 18 months (first patient enrolled to last patient visit completed) | Participants |
From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | VE800 combination treatment with nivolumab (Melanoma) | Subjects received 5 days of oral vancomycin, followed by daily VE800 in combination with nivolumab every 4 weeks. VE800: VE800 is a PO LBP consisting of 11 distinct nonpathogenic, nontoxigenic, commensal bacterial strains manufactured under GMP conditions. These strains were selected for their ability to induce an immune response. Nivolumab: Nivolumab is an approved medication that blocks antibodies for certain types of cancer. Vancomycin Oral Capsule: Vancomycin is an antibiotic used to treat or prevent infection. | 9 | 21 | 5 | 21 | 13 | 21 |
| EG001 | VE800 combination treatment with nivolumab (Gastric) | Subjects received 5 days of oral vancomycin, followed by daily VE800 in combination with nivolumab every 4 weeks. VE800: VE800 is a PO LBP consisting of 11 distinct nonpathogenic, nontoxigenic, commensal bacterial strains manufactured under GMP conditions. These strains were selected for their ability to induce an immune response. Nivolumab: Nivolumab is an approved medication that blocks antibodies for certain types of cancer. Vancomycin Oral Capsule: Vancomycin is an antibiotic used to treat or prevent infection. | 12 | 21 | 9 | 21 | 16 | 21 |
| EG002 | VE800 combination treatment with nivolumab (Colorectal) | Subjects received 5 days of oral vancomycin, followed by daily VE800 in combination with nivolumab every 4 weeks. VE800: VE800 is a PO LBP consisting of 11 distinct nonpathogenic, nontoxigenic, commensal bacterial strains manufactured under GMP conditions. These strains were selected for their ability to induce an immune response. Nivolumab: Nivolumab is an approved medication that blocks antibodies for certain types of cancer. Vancomycin Oral Capsule: Vancomycin is an antibiotic used to treat or prevent infection. | 10 | 14 | 2 | 14 | 11 | 14 |
| EG003 | VE800 combination treatment with nivolumab (Total) | Subjects received 5 days of oral vancomycin, followed by daily VE800 in combination with nivolumab every 4 weeks. VE800: VE800 is a PO LBP consisting of 11 distinct nonpathogenic, nontoxigenic, commensal bacterial strains manufactured under GMP conditions. These strains were selected for their ability to induce an immune response. Nivolumab: Nivolumab is an approved medication that blocks antibodies for certain types of cancer. Vancomycin Oral Capsule: Vancomycin is an antibiotic used to treat or prevent infection. | 31 | 56 | 16 | 56 | 40 | 56 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Plural Effusion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Pneumonia Aspiration | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Dysphagia | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Abdominal Pain | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Gastrointestinal Fistula | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Intestinal Perforation | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Arthritis Infective | Infections and infestations | Non-systematic Assessment |
| ||
| Bacteremia | Infections and infestations | Non-systematic Assessment |
| ||
| Sepsis | Infections and infestations | Non-systematic Assessment |
| ||
| Alanine aminotransferase Increased | Investigations | Non-systematic Assessment |
| ||
| Aspartate Aminotransferase Increased | Investigations | Non-systematic Assessment |
| ||
| Blood Creatine Phosphokinase Increased | Investigations | Non-systematic Assessment |
| ||
| Troponin Increased | Investigations | Non-systematic Assessment |
| ||
| Pain | General disorders | Non-systematic Assessment |
| ||
| Hepatitis | Hepatobiliary disorders | Non-systematic Assessment |
| ||
| Spinal Fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Malnutrition | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Myositis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Cancer Pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Cerebrovascular Accident | Nervous system disorders | Non-systematic Assessment |
| ||
| Depression | Psychiatric disorders | Non-systematic Assessment |
| ||
| Superior Vena cava Syndrome | Vascular disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Decreased Appetite | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Fatigue | General disorders | Non-systematic Assessment |
| ||
| Anaemia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Abdominal Pain | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Abdominal Distention | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Abdominal Pain - Upper | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Dyspepsia | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Dysphagia | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Hyponatremia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hypokalemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hypoalbuminemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Oedema Peripheral | General disorders | Non-systematic Assessment |
| ||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Plural Effusion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Pruritus | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Myalgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Urinary Tract Infection | Infections and infestations | Non-systematic Assessment |
| ||
| Lymphocyte Count Decrease | Investigations | Non-systematic Assessment |
| ||
| Headache | Nervous system disorders | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeffrey Silber | Vedanta Biosciences | (857) 706-1427 | ConsortiumIO-ctinquiries@vedantabio.com |
| Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 3, 2021 | Oct 13, 2022 | SAP_002.pdf |
Not provided
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D008545 | Melanoma |
| D013274 | Stomach Neoplasms |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D007414 | Intestinal Neoplasms |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| D014640 | Vancomycin |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
Not provided
Not provided
|
| CRC-MSS |
|
|
| Total |
|
|
| Male |
|
| Gastric/GEJ |
|
|
| CRC-MSS |
|
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Gastric/GEJ |
|
|
| CRS/MSS |
|
|
| Any Treatment Related Adverse Event |
|
| Treatment Related Adverse Event : Vancomycin Related |
|
| Treatment Related Adverse Event : Nivolumab Related |
|
| Treatment Related Adverse Event : VE800 Related |
|
| Any Grade 3 or Greater Adverse Event |
|
| Grade 3 or Greater Adverse Event : Vancomycin Related |
|
| Grade 3 or Greater Adverse Event: Nivolumab Related |
|
| Grade 3 or Greater Adverse Event: VE800 Related |
|
| Any Serious Adverse Event |
|
| Serious Adverse Event: Vancomycin Related |
|
| Serious Adverse Event: Nivolumab Related |
|
| Serious Adverse Event: VE800 Related |
|
| Any Adverse Events of Special Interest |
|
| Adverse Events of Special Interest: Vancomycin Related |
|
| Adverse Events of Special Interest: Nivolumab Related |
|
| Adverse Events of Special Interest: VE800 Related |
|
| Any Immune-Related Adverse Events |
|
| Immune-Related Adverse Events: Vancomycin Related |
|
| Immune-Related Adverse Events: Nivolumab Related |
|
| Immune-Related Adverse Events: VE800 Related |
|
| Any Adverse Events Leading to Discontinuation of any Study Drug |
|
| Adverse Events Leading to Discontinuation of any Study Drug: Vancomycin Related |
|
| Adverse Events Leading to Discontinuation of any Study Drug: Nivolumab Related |
|
| Adverse Events Leading to Discontinuation of any Study Drug: VE800 Related |
|
| Any Adverse Events Leading to Interruption of Study Drug |
|
| Adverse Events Leading to Interruption of Study Drug: Vancomycin Related |
|
| Adverse Events Leading to Interruption of Study Drug: Nivolumab Related |
|
| Adverse Events Leading to Interruption of Study Drug: VE800 Related |
|
| Any Adverse Events Leading to Study Discontinuation |
|
| Adverse Events Leading to Study Discontinuation: Vancomycin Related |
|
| Adverse Events Leading to Study Discontinuation: Nivolumab Related |
|
| Adverse Events Leading to Study Discontinuation: VE800 Related |
|
| Any Adverse Event with an Outcome of Death |
|
|
|
|
|
|
|
|
| NE |
|
| SD |
|
| PD |
|
| SD |
|
| PD |
|
| PR |
|