Metastatic Cancer, Melanoma, Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, Colorectal Cancer
Conditions
Keywords
Metastatic Cancer, VE800, Nivolumab, Opdivo, Melanoma, Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, GEJ Adenocarcinoma, Colorectal Cancer, CRC-MSS, Vedanta, BMS
Brief summary
This study evaluated the safety and efficacy of VE800 in combination with nivolumab in patients with selected types of advanced or metastatic cancer
Detailed description
CONSORTIUM-IO was the first-in-human multicenter, open-label study; the main objectives were to evaluate: * Safety and tolerability of VE800 in combination with nivolumab * Efficacy as measured by objective response rate 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.
Interventions
BIOLOGICALVE800
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.
DRUGNivolumab
Nivolumab is an approved medication that blocks antibodies for certain types of cancer.
Vancomycin is an antibiotic used to treat or prevent infection.
Sponsors
Bristol-Myers Squibb
Vedanta Biosciences, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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: * Melanoma * Gastric/gastroesophageal junction (GEJ) adenocarcinoma * Colorectal cancer (microsatellite-stable) (CRC-MSS)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Partial Inclusion Criteria: * Patients with advanced or metastatic cancer who had received no more than 3 lines of prior systemic therapy for advanced/metastatic disease. * Histologically diagnosed advanced (unresectable) or metastatic cancer with at least one measurable lesion as per RECIST 1.1 * Tumor lesions amenable for biopsy, if deemed safe by the investigator * Toxicity from prior cancer therapy should have resolved to Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤ 1 (excluding alopecia and neuropathy, where up to Grade 2 residual was allowed) Partial
Exclusion criteria
* Prior treatment with immune checkpoint inhibitor (iCPI) (Note: this criterion did not apply to patients with melanoma) * Receipt of any conventional or investigational systemic anti-cancer therapy within 21 days prior to the first dose of vancomycin * Concurrent chemotherapy, immunotherapy, biologic, or hormonal anti-cancer therapy. Agents such as bisphosphonates or denosumab were acceptable as prophylaxis for bone metastasis. * Patients must not have received a transfusion (platelets or red blood cells) within 4 weeks of the first dose of study treatment * Patients with an active, known or suspected autoimmune disease. Patients with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment were permitted to enroll. * Patients with known active hepatitis (e.g., hepatitis B or C) NOTE: Patients with previously treated hepatitis B or C were permitted to enroll if there was evidence of documented resolution of infection. * Received a fecal transplant, spore or other preparation of fecal material, isolated bacterial products, genetically modified bacteria, or VE800
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Safety and tolerability of VE800 in combination with nivolumab: Number of Participants with Adverse Events |
| Objective Response Rate (ORR) | 18 months (first patient enrolled to last patient visit completed) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease Control Rate (DCR) | Up to 2 years | 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. |
| Progression-Free Survival (PFS) | 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. | 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 |
| Overall Survival (OS) | 18 months (first patient enrolled to last patient visit completed) | Overall Survival (OS) as measured from the date of start of treatment to the date of death by any cause will also be evaluated. |
| Duration of Response (DOR) | Up to two years | 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. |
| Degree of VE800 Bacterial Strain Colonization in Stool | 18 months (first patient enrolled to last patient visit completed) | Measured by pharmacokinetics (PK) of VE800 colonization in stool |
| Duration of VE800 Bacterial Strain Colonization in Stool | 18 months (first patient enrolled to last patient visit completed) | Measured by pharmacokinetics (PK) of VE800 colonization in stool |
| Detection of VE800 Bacterial Strain Colonization in Stool | 18 months (first patient enrolled to last patient visit completed) | Detection of VE800 bacterial strain colonization in stool was measured by pharmacokinetics (PK) of VE800 |
| Best Overall Response | Up to 2 years | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 55 |
| Total | 55 |
Baseline characteristics
| Characteristic | VE800 combination treatment with nivolumab |
|---|---|
| Age, Continuous CRC-MSS | 56.6 years STANDARD_DEVIATION 13.44 |
| Age, Continuous Gastric/GEJ | 62.6 years STANDARD_DEVIATION 11.51 |
| Age, Continuous Melanoma | 60.2 years STANDARD_DEVIATION 17.53 |
| Age, Continuous Total | 60.1 years STANDARD_DEVIATION 14.47 |
| Race (NIH/OMB) CRS/MSS American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) CRS/MSS Asian | 0 Participants |
| Race (NIH/OMB) CRS/MSS Black or African American | 1 Participants |
| Race (NIH/OMB) CRS/MSS More than one race | 0 Participants |
| Race (NIH/OMB) CRS/MSS Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) CRS/MSS Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) CRS/MSS White | 13 Participants |
| Race (NIH/OMB) Gastric/GEJ American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Gastric/GEJ Asian | 1 Participants |
| Race (NIH/OMB) Gastric/GEJ Black or African American | 1 Participants |
| Race (NIH/OMB) Gastric/GEJ More than one race | 0 Participants |
| Race (NIH/OMB) Gastric/GEJ Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Gastric/GEJ Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) Gastric/GEJ White | 17 Participants |
| Race (NIH/OMB) Melanoma American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Melanoma Asian | 0 Participants |
| Race (NIH/OMB) Melanoma Black or African American | 0 Participants |
| Race (NIH/OMB) Melanoma More than one race | 0 Participants |
| Race (NIH/OMB) Melanoma Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Melanoma Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) Melanoma White | 21 Participants |
| Sex: Female, Male CRC-MSS Female | 6 Participants |
| Sex: Female, Male CRC-MSS Male | 8 Participants |
| Sex: Female, Male Gastric/GEJ Female | 7 Participants |
| Sex: Female, Male Gastric/GEJ Male | 13 Participants |
| Sex: Female, Male Melanoma Female | 11 Participants |
| Sex: Female, Male Melanoma Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 9 / 21 | 12 / 21 | 10 / 14 | 31 / 56 |
| other Total, other adverse events | 13 / 21 | 16 / 21 | 11 / 14 | 40 / 56 |
| serious Total, serious adverse events | 5 / 21 | 9 / 21 | 2 / 14 | 16 / 56 |
Outcome results
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.
Time frame: 18 months (first patient enrolled to last patient visit completed)
Population: The analysis population included all subjects who received at least one dose of VE800 or nivolumab.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| VE800 combination treatment with nivolumab (Melanoma) | Objective Response Rate (ORR) | Gastric | 1 Participants |
| VE800 combination treatment with nivolumab (Melanoma) | Objective Response Rate (ORR) | Melanoma | 0 Participants |
| VE800 combination treatment with nivolumab (Melanoma) | Objective Response Rate (ORR) | CRC | 0 Participants |
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
Time frame: From the first dose to the last dose (up to 56.7 weeks), plus 100 days of post-treatment follow-up
Population: 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| VE800 combination treatment with nivolumab (Melanoma) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Any Adverse Events Leading to Discontinuation of any Study Drug | 1 participants |
| VE800 combination treatment with nivolumab (Melanoma) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Any Immune-Related Adverse Events | 1 participants |
| VE800 combination treatment with nivolumab (Melanoma) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Immune-Related Adverse Events: Vancomycin Related | 0 participants |
| VE800 combination treatment with nivolumab (Melanoma) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Any Adverse Events Leading to Interruption of Study Drug | 0 participants |
| VE800 combination treatment with nivolumab (Melanoma) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Immune-Related Adverse Events: Nivolumab Related | 1 participants |
| VE800 combination treatment with nivolumab (Melanoma) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Any Treatment Related Adverse Event | 9 participants |
| VE800 combination treatment with nivolumab (Melanoma) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Immune-Related Adverse Events: VE800 Related | 1 participants |
| VE800 combination treatment with nivolumab (Melanoma) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Adverse Events Leading to Discontinuation of any Study Drug: VE800 Related | 0 participants |
| VE800 combination treatment with nivolumab (Melanoma) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Adverse Events Leading to Interruption of Study Drug: Vancomycin Related | NA participants |
| VE800 combination treatment with nivolumab (Melanoma) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Any Grade 3 or Greater Adverse Event | 6 participants |
| VE800 combination treatment with nivolumab (Melanoma) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Adverse Events Leading to Discontinuation of any Study Drug: Vancomycin Related | NA participants |
| VE800 combination treatment with nivolumab (Melanoma) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Adverse Events Leading to Discontinuation of any Study Drug: Nivolumab Related | 0 participants |
| VE800 combination treatment with nivolumab (Melanoma) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Grade 3 or Greater Adverse Event : Vancomycin Related | 0 participants |
| VE800 combination treatment with nivolumab (Melanoma) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Adverse Events Leading to Study Discontinuation: Nivolumab Related | 0 participants |
| VE800 combination treatment with nivolumab (Melanoma) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Grade 3 or Greater Adverse Event: Nivolumab Related | 0 participants |
| VE800 combination treatment with nivolumab (Melanoma) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Any Adverse Event with an Outcome of Death | 0 participants |
| VE800 combination treatment with nivolumab (Melanoma) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Grade 3 or Greater Adverse Event: VE800 Related | 0 participants |
| VE800 combination treatment with nivolumab (Melanoma) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Treatment Related Adverse Event : Vancomycin Related | 1 participants |
| VE800 combination treatment with nivolumab (Melanoma) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Adverse Events Leading to Study Discontinuation: Vancomycin Related | 0 participants |
| VE800 combination treatment with nivolumab (Melanoma) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Any Serious Adverse Event | 5 participants |
| VE800 combination treatment with nivolumab (Melanoma) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Serious Adverse Event: Vancomycin Related | 0 participants |
| VE800 combination treatment with nivolumab (Melanoma) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Any Treatment-emergent Adverse Event | 16 participants |
| VE800 combination treatment with nivolumab (Melanoma) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Any Adverse Events Leading to Study Discontinuation | 0 participants |
| VE800 combination treatment with nivolumab (Melanoma) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Serious Adverse Event: Nivolumab Related | 0 participants |
| VE800 combination treatment with nivolumab (Melanoma) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Serious Adverse Event: VE800 Related | 0 participants |
| VE800 combination treatment with nivolumab (Melanoma) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Treatment Related Adverse Event : Nivolumab Related | 8 participants |
| VE800 combination treatment with nivolumab (Melanoma) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Adverse Events Leading to Interruption of Study Drug: VE800 Related | 0 participants |
| VE800 combination treatment with nivolumab (Melanoma) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Any Adverse Events of Special Interest | 1 participants |
| VE800 combination treatment with nivolumab (Melanoma) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Adverse Events of Special Interest: Vancomycin Related | 0 participants |
| VE800 combination treatment with nivolumab (Melanoma) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Adverse Events Leading to Interruption of Study Drug: Nivolumab Related | 0 participants |
| VE800 combination treatment with nivolumab (Melanoma) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Adverse Events of Special Interest: Nivolumab Related | 1 participants |
| VE800 combination treatment with nivolumab (Melanoma) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Adverse Events Leading to Study Discontinuation: VE800 Related | 0 participants |
| VE800 combination treatment with nivolumab (Melanoma) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Adverse Events of Special Interest: VE800 Related | 1 participants |
| VE800 combination treatment with nivolumab (Melanoma) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Treatment Related Adverse Event : VE800 Related | 3 participants |
| VE800 combination treatment with nivolumab (Gastric) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Grade 3 or Greater Adverse Event: VE800 Related | 1 participants |
| VE800 combination treatment with nivolumab (Gastric) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Any Adverse Event with an Outcome of Death | 0 participants |
| VE800 combination treatment with nivolumab (Gastric) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Any Immune-Related Adverse Events | 2 participants |
| VE800 combination treatment with nivolumab (Gastric) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Treatment Related Adverse Event : VE800 Related | 3 participants |
| VE800 combination treatment with nivolumab (Gastric) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Any Adverse Events Leading to Interruption of Study Drug | 5 participants |
| VE800 combination treatment with nivolumab (Gastric) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Adverse Events of Special Interest: VE800 Related | 1 participants |
| VE800 combination treatment with nivolumab (Gastric) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Immune-Related Adverse Events: Vancomycin Related | 0 participants |
| VE800 combination treatment with nivolumab (Gastric) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Adverse Events Leading to Interruption of Study Drug: Vancomycin Related | NA participants |
| VE800 combination treatment with nivolumab (Gastric) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Any Serious Adverse Event | 9 participants |
| VE800 combination treatment with nivolumab (Gastric) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Immune-Related Adverse Events: Nivolumab Related | 2 participants |
| VE800 combination treatment with nivolumab (Gastric) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Treatment Related Adverse Event : Vancomycin Related | 3 participants |
| VE800 combination treatment with nivolumab (Gastric) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Adverse Events Leading to Discontinuation of any Study Drug: VE800 Related | 1 participants |
| VE800 combination treatment with nivolumab (Gastric) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Any Adverse Events Leading to Study Discontinuation | 1 participants |
| VE800 combination treatment with nivolumab (Gastric) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Immune-Related Adverse Events: VE800 Related | 0 participants |
| VE800 combination treatment with nivolumab (Gastric) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Adverse Events Leading to Study Discontinuation: Nivolumab Related | 1 participants |
| VE800 combination treatment with nivolumab (Gastric) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Any Adverse Events of Special Interest | 2 participants |
| VE800 combination treatment with nivolumab (Gastric) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Serious Adverse Event: Vancomycin Related | 0 participants |
| VE800 combination treatment with nivolumab (Gastric) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Any Adverse Events Leading to Discontinuation of any Study Drug | 1 participants |
| VE800 combination treatment with nivolumab (Gastric) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Treatment Related Adverse Event : Nivolumab Related | 8 participants |
| VE800 combination treatment with nivolumab (Gastric) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Adverse Events Leading to Discontinuation of any Study Drug: Nivolumab Related | 1 participants |
| VE800 combination treatment with nivolumab (Gastric) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Adverse Events Leading to Interruption of Study Drug: Nivolumab Related | 2 participants |
| VE800 combination treatment with nivolumab (Gastric) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Adverse Events Leading to Discontinuation of any Study Drug: Vancomycin Related | NA participants |
| VE800 combination treatment with nivolumab (Gastric) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Any Grade 3 or Greater Adverse Event | 8 participants |
| VE800 combination treatment with nivolumab (Gastric) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Adverse Events of Special Interest: Nivolumab Related | 2 participants |
| VE800 combination treatment with nivolumab (Gastric) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Any Treatment Related Adverse Event | 9 participants |
| VE800 combination treatment with nivolumab (Gastric) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Serious Adverse Event: Nivolumab Related | 3 participants |
| VE800 combination treatment with nivolumab (Gastric) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Grade 3 or Greater Adverse Event : Vancomycin Related | 1 participants |
| VE800 combination treatment with nivolumab (Gastric) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Any Treatment-emergent Adverse Event | 19 participants |
| VE800 combination treatment with nivolumab (Gastric) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Adverse Events Leading to Study Discontinuation: VE800 Related | 1 participants |
| VE800 combination treatment with nivolumab (Gastric) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Adverse Events Leading to Interruption of Study Drug: VE800 Related | 0 participants |
| VE800 combination treatment with nivolumab (Gastric) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Grade 3 or Greater Adverse Event: Nivolumab Related | 3 participants |
| VE800 combination treatment with nivolumab (Gastric) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Adverse Events of Special Interest: Vancomycin Related | 0 participants |
| VE800 combination treatment with nivolumab (Gastric) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Adverse Events Leading to Study Discontinuation: Vancomycin Related | 0 participants |
| VE800 combination treatment with nivolumab (Gastric) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Serious Adverse Event: VE800 Related | 1 participants |
| VE800 combination treatment with nivolumab (Colorectal) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Any Adverse Events Leading to Study Discontinuation | 0 participants |
| VE800 combination treatment with nivolumab (Colorectal) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Immune-Related Adverse Events: Vancomycin Related | 0 participants |
| VE800 combination treatment with nivolumab (Colorectal) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Any Treatment-emergent Adverse Event | 12 participants |
| VE800 combination treatment with nivolumab (Colorectal) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Any Treatment Related Adverse Event | 6 participants |
| VE800 combination treatment with nivolumab (Colorectal) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Treatment Related Adverse Event : Vancomycin Related | 1 participants |
| VE800 combination treatment with nivolumab (Colorectal) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Treatment Related Adverse Event : Nivolumab Related | 5 participants |
| VE800 combination treatment with nivolumab (Colorectal) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Treatment Related Adverse Event : VE800 Related | 3 participants |
| VE800 combination treatment with nivolumab (Colorectal) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Any Grade 3 or Greater Adverse Event | 2 participants |
| VE800 combination treatment with nivolumab (Colorectal) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Grade 3 or Greater Adverse Event : Vancomycin Related | 0 participants |
| VE800 combination treatment with nivolumab (Colorectal) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Grade 3 or Greater Adverse Event: Nivolumab Related | 0 participants |
| VE800 combination treatment with nivolumab (Colorectal) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Grade 3 or Greater Adverse Event: VE800 Related | 0 participants |
| VE800 combination treatment with nivolumab (Colorectal) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Any Serious Adverse Event | 2 participants |
| VE800 combination treatment with nivolumab (Colorectal) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Serious Adverse Event: Vancomycin Related | 0 participants |
| VE800 combination treatment with nivolumab (Colorectal) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Serious Adverse Event: Nivolumab Related | 1 participants |
| VE800 combination treatment with nivolumab (Colorectal) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Serious Adverse Event: VE800 Related | 0 participants |
| VE800 combination treatment with nivolumab (Colorectal) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Any Adverse Events of Special Interest | 0 participants |
| VE800 combination treatment with nivolumab (Colorectal) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Adverse Events of Special Interest: Vancomycin Related | 0 participants |
| VE800 combination treatment with nivolumab (Colorectal) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Adverse Events of Special Interest: Nivolumab Related | 0 participants |
| VE800 combination treatment with nivolumab (Colorectal) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Adverse Events of Special Interest: VE800 Related | 0 participants |
| VE800 combination treatment with nivolumab (Colorectal) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Any Immune-Related Adverse Events | 0 participants |
| VE800 combination treatment with nivolumab (Colorectal) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Immune-Related Adverse Events: Nivolumab Related | 0 participants |
| VE800 combination treatment with nivolumab (Colorectal) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Immune-Related Adverse Events: VE800 Related | 0 participants |
| VE800 combination treatment with nivolumab (Colorectal) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Any Adverse Events Leading to Discontinuation of any Study Drug | 0 participants |
| VE800 combination treatment with nivolumab (Colorectal) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Adverse Events Leading to Discontinuation of any Study Drug: Vancomycin Related | NA participants |
| VE800 combination treatment with nivolumab (Colorectal) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Adverse Events Leading to Discontinuation of any Study Drug: Nivolumab Related | 0 participants |
| VE800 combination treatment with nivolumab (Colorectal) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Adverse Events Leading to Discontinuation of any Study Drug: VE800 Related | 0 participants |
| VE800 combination treatment with nivolumab (Colorectal) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Any Adverse Events Leading to Interruption of Study Drug | 3 participants |
| VE800 combination treatment with nivolumab (Colorectal) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Adverse Events Leading to Interruption of Study Drug: Vancomycin Related | NA participants |
| VE800 combination treatment with nivolumab (Colorectal) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Adverse Events Leading to Interruption of Study Drug: Nivolumab Related | 3 participants |
| VE800 combination treatment with nivolumab (Colorectal) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Adverse Events Leading to Interruption of Study Drug: VE800 Related | 0 participants |
| VE800 combination treatment with nivolumab (Colorectal) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Adverse Events Leading to Study Discontinuation: Vancomycin Related | 0 participants |
| VE800 combination treatment with nivolumab (Colorectal) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Adverse Events Leading to Study Discontinuation: Nivolumab Related | 0 participants |
| VE800 combination treatment with nivolumab (Colorectal) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Adverse Events Leading to Study Discontinuation: VE800 Related | 0 participants |
| VE800 combination treatment with nivolumab (Colorectal) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Any Adverse Event with an Outcome of Death | 0 participants |
| VE800 combination treatment with nivolumab (Total) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Treatment Related Adverse Event : Nivolumab Related | 21 participants |
| VE800 combination treatment with nivolumab (Total) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Any Adverse Events Leading to Interruption of Study Drug | 8 participants |
| VE800 combination treatment with nivolumab (Total) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Adverse Events of Special Interest: VE800 Related | 2 participants |
| VE800 combination treatment with nivolumab (Total) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Adverse Events of Special Interest: Nivolumab Related | 3 participants |
| VE800 combination treatment with nivolumab (Total) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Treatment Related Adverse Event : Vancomycin Related | 5 participants |
| VE800 combination treatment with nivolumab (Total) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Adverse Events Leading to Interruption of Study Drug: Vancomycin Related | NA participants |
| VE800 combination treatment with nivolumab (Total) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Adverse Events of Special Interest: Vancomycin Related | 0 participants |
| VE800 combination treatment with nivolumab (Total) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Any Adverse Events of Special Interest | 3 participants |
| VE800 combination treatment with nivolumab (Total) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Any Adverse Event with an Outcome of Death | 0 participants |
| VE800 combination treatment with nivolumab (Total) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Adverse Events Leading to Interruption of Study Drug: Nivolumab Related | 5 participants |
| VE800 combination treatment with nivolumab (Total) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Serious Adverse Event: VE800 Related | 1 participants |
| VE800 combination treatment with nivolumab (Total) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Serious Adverse Event: Nivolumab Related | 4 participants |
| VE800 combination treatment with nivolumab (Total) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Adverse Events Leading to Study Discontinuation: VE800 Related | 1 participants |
| VE800 combination treatment with nivolumab (Total) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Adverse Events Leading to Interruption of Study Drug: VE800 Related | 0 participants |
| VE800 combination treatment with nivolumab (Total) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Serious Adverse Event: Vancomycin Related | 0 participants |
| VE800 combination treatment with nivolumab (Total) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Any Serious Adverse Event | 16 participants |
| VE800 combination treatment with nivolumab (Total) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Any Grade 3 or Greater Adverse Event | 16 participants |
| VE800 combination treatment with nivolumab (Total) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Any Adverse Events Leading to Study Discontinuation | 1 participants |
| VE800 combination treatment with nivolumab (Total) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Grade 3 or Greater Adverse Event: VE800 Related | 1 participants |
| VE800 combination treatment with nivolumab (Total) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Grade 3 or Greater Adverse Event: Nivolumab Related | 3 participants |
| VE800 combination treatment with nivolumab (Total) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Any Treatment Related Adverse Event | 24 participants |
| VE800 combination treatment with nivolumab (Total) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Adverse Events Leading to Study Discontinuation: Vancomycin Related | 0 participants |
| VE800 combination treatment with nivolumab (Total) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Grade 3 or Greater Adverse Event : Vancomycin Related | 1 participants |
| VE800 combination treatment with nivolumab (Total) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Treatment Related Adverse Event : VE800 Related | 9 participants |
| VE800 combination treatment with nivolumab (Total) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Adverse Events Leading to Discontinuation of any Study Drug: Vancomycin Related | NA participants |
| VE800 combination treatment with nivolumab (Total) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Any Adverse Events Leading to Discontinuation of any Study Drug | 2 participants |
| VE800 combination treatment with nivolumab (Total) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Any Treatment-emergent Adverse Event | 47 participants |
| VE800 combination treatment with nivolumab (Total) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Adverse Events Leading to Discontinuation of any Study Drug: Nivolumab Related | 1 participants |
| VE800 combination treatment with nivolumab (Total) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Immune-Related Adverse Events: VE800 Related | 1 participants |
| VE800 combination treatment with nivolumab (Total) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Immune-Related Adverse Events: Nivolumab Related | 3 participants |
| VE800 combination treatment with nivolumab (Total) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Adverse Events Leading to Study Discontinuation: Nivolumab Related | 1 participants |
| VE800 combination treatment with nivolumab (Total) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Adverse Events Leading to Discontinuation of any Study Drug: VE800 Related | 1 participants |
| VE800 combination treatment with nivolumab (Total) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Immune-Related Adverse Events: Vancomycin Related | 0 participants |
| VE800 combination treatment with nivolumab (Total) | Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events | Any Immune-Related Adverse Events | 3 participants |
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.
Time frame: Up to 2 years
Population: The analysis population included all subjects who received at least one dose of VE800 or nivolumab.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| VE800 combination treatment with nivolumab (Melanoma) | Best Overall Response | Melanoma | PR | 0 Participants |
| VE800 combination treatment with nivolumab (Melanoma) | Best Overall Response | CRC | CR | 0 Participants |
| VE800 combination treatment with nivolumab (Melanoma) | Best Overall Response | CRC | NE | 0 Participants |
| VE800 combination treatment with nivolumab (Melanoma) | Best Overall Response | CRC | Unknown | 1 Participants |
| VE800 combination treatment with nivolumab (Melanoma) | Best Overall Response | CRC | PR | 0 Participants |
| VE800 combination treatment with nivolumab (Melanoma) | Best Overall Response | CRC | SD | 3 Participants |
| VE800 combination treatment with nivolumab (Melanoma) | Best Overall Response | CRC | PD | 10 Participants |
| VE800 combination treatment with nivolumab (Melanoma) | Best Overall Response | Melanoma | CR | 0 Participants |
| VE800 combination treatment with nivolumab (Melanoma) | Best Overall Response | Melanoma | Unknown | 2 Participants |
| VE800 combination treatment with nivolumab (Melanoma) | Best Overall Response | Melanoma | NE | 0 Participants |
| VE800 combination treatment with nivolumab (Melanoma) | Best Overall Response | Melanoma | SD | 9 Participants |
| VE800 combination treatment with nivolumab (Melanoma) | Best Overall Response | Melanoma | PD | 9 Participants |
| VE800 combination treatment with nivolumab (Melanoma) | Best Overall Response | Gastric | CR | 0 Participants |
| VE800 combination treatment with nivolumab (Melanoma) | Best Overall Response | Gastric | NE | 0 Participants |
| VE800 combination treatment with nivolumab (Melanoma) | Best Overall Response | Gastric | Unknown | 1 Participants |
| VE800 combination treatment with nivolumab (Melanoma) | Best Overall Response | Gastric | SD | 2 Participants |
| VE800 combination treatment with nivolumab (Melanoma) | Best Overall Response | Gastric | PD | 16 Participants |
| VE800 combination treatment with nivolumab (Melanoma) | Best Overall Response | Gastric | PR | 1 Participants |
Secondary
Degree of VE800 Bacterial Strain Colonization in Stool
Measured by pharmacokinetics (PK) of VE800 colonization in stool
Time frame: 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
Time frame: 18 months (first patient enrolled to last patient visit completed)
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.
Time frame: Up to 2 years
Population: The analysis population included all subjects who received at least one dose of VE800 or nivolumab.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| VE800 combination treatment with nivolumab (Melanoma) | Disease Control Rate (DCR) | Gastric | 3 Participants |
| VE800 combination treatment with nivolumab (Melanoma) | Disease Control Rate (DCR) | Melanoma | 9 Participants |
| VE800 combination treatment with nivolumab (Melanoma) | Disease Control Rate (DCR) | CRC | 3 Participants |
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.
Time frame: Up to two years
Population: The analysis population includes all subjects who received at least one dose of VE800 or nivolumab and had an objective response.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| VE800 combination treatment with nivolumab (Melanoma) | Duration of Response (DOR) | Gastric | 5.6 months |
Secondary
Duration of VE800 Bacterial Strain Colonization in Stool
Measured by pharmacokinetics (PK) of VE800 colonization in stool
Time frame: 18 months (first patient enrolled to last patient visit completed)
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.
Time frame: 18 months (first patient enrolled to last patient visit completed)
Population: The analysis population included all subjects who received at least one dose of VE800 or nivolumab.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| VE800 combination treatment with nivolumab (Melanoma) | Overall Survival (OS) | Gastric | 5.8 months |
| VE800 combination treatment with nivolumab (Melanoma) | Overall Survival (OS) | Melanoma | NA months |
| VE800 combination treatment with nivolumab (Melanoma) | Overall Survival (OS) | Colorectal | 7.6 months |
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
Time frame: 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.
Population: The analysis population included all subjects who received at least one dose of VE800 or nivolumab.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| VE800 combination treatment with nivolumab (Melanoma) | Progression-Free Survival (PFS) | Gastric | 1.8 months |
| VE800 combination treatment with nivolumab (Melanoma) | Progression-Free Survival (PFS) | Melanoma | 1.9 months |
| VE800 combination treatment with nivolumab (Melanoma) | Progression-Free Survival (PFS) | CRC | 1.8 months |
| VE800 combination treatment with nivolumab (Melanoma) | Progression-Free Survival (PFS) | Total | 1.8 months |