Trial Outcomes & Findings for A Trial of Perioperative CV301 Vaccination in Combination With Nivolumab and Systemic Chemotherapy for Metastatic CRC (NCT NCT03547999)
NCT ID: NCT03547999
Last Updated: 2025-07-22
Results Overview
3-year Overall Survival (OS) rate is defined as the percentage of patients who are still alive at 3 years.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
17 participants
Primary outcome timeframe
3 years
Results posted on
2025-07-22
Participant Flow
Participant milestones
| Measure |
Arm A - Control
mFOLFOX6 and Nivolumab every 2 weeks for 4 cycles. After neoadjuvant therapy, patients will be re-evaluated for surgical resection. Once patients in the post-operative period are deemed ready to begin therapy, patients in the control arm will then undergo another 8 cycles of mFOLFOX6 in addition to Nivolumab. After this, Nivolumab will be given every 4 weeks completing therapy at week 110.
mFOLFOX6: Arm A will receive mFOLFOX6 every 2 weeks for 4 cycles. Once patients in the post-operative period are deemed ready to begin therapy, patients in the control arm will then undergo another 8 cycles of mFOLFOX6.
Nivolumab: Nivolumab at a dose of 240 mg as a 30 minute IV infusion every 2 weeks until progression. Arm B will receive Nivolumab starting with the vaccinations. Arm A will begin the Nivolumab with the initiation mFOLFOX.
|
Arm B - Experimental
Two doses of Nivolumab and MVA-BN-CV301 will given 2 weeks apart (Days -28, -14), followed by four doses of Nivolumab plus FPV-CV301 given 2 weeks apart concurrently with mFOLFOX6 for 4 cycles. After neoadjuvant therapy, patients will be re-evaluated for surgical resection. Once patients in the post-operative period are deemed ready to begin therapy, patients will receive 8 cycles of mFOLFOX6 in addition to Nivolumab and FVP-CV301 boosters with the first two given on Day 0 and 14 and then every 4 weeks.
mFOLFOX6: Arm B will receive mFOLFOX6 every 2 weeks for 4 cycles. Once patients in the post-operative period are deemed ready to begin therapy, patients will then undergo another 8 cycles of mFOLFOX6.
MVA-BN-CV301: Arm B will receive MVA-BN-CV301 in 4 injections of 4 x 10(8) infectious units/0.5 mL given subcutaneously prior to the start of chemotherapy on days -28 and -14.
FPV-CV301: Arm B will receive FPV-CV301 in 1 dose of 1 x 10(9) infectious units/0.5 mL given subcutaneously concurrently with chemotherapy on days 0, 14, 28 and 42 pre-operatively, and FVP-CV301 boosters on day 0 and 14 and then every 4 weeks (day 42, 70, 98). After day 98, FVP-CV301 will then be administered every twelve weeks completing therapy at week 110.
Nivolumab: Nivolumab at a dose of 240 mg as a 30 minute IV infusion every 2 weeks until progression.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
9
|
|
Overall Study
COMPLETED
|
8
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Trial of Perioperative CV301 Vaccination in Combination With Nivolumab and Systemic Chemotherapy for Metastatic CRC
Baseline characteristics by cohort
| Measure |
Arm A - Control
n=8 Participants
mFOLFOX6 and Nivolumab every 2 weeks for 4 cycles. After neoadjuvant therapy, patients will be re-evaluated for surgical resection. Once patients in the post-operative period are deemed ready to begin therapy, patients in the control arm will then undergo another 8 cycles of mFOLFOX6 in addition to Nivolumab. After this, Nivolumab will be given every 4 weeks completing therapy at week 110.
mFOLFOX6: Arm A will receive mFOLFOX6 every 2 weeks for 4 cycles. Once patients in the post-operative period are deemed ready to begin therapy, patients in the control arm will then undergo another 8 cycles of mFOLFOX6.
Nivolumab: Nivolumab at a dose of 240 mg as a 30 minute IV infusion every 2 weeks until progression. Arm B will receive Nivolumab starting with the vaccinations. Arm A will begin the Nivolumab with the initiation mFOLFOX.
|
Arm B - Experimental
n=9 Participants
Two doses of Nivolumab and MVA-BN-CV301 will given 2 weeks apart (Days -28, -14), followed by four doses of Nivolumab plus FPV-CV301 given 2 weeks apart concurrently with mFOLFOX6 for 4 cycles. After neoadjuvant therapy, patients will be re-evaluated for surgical resection. Once patients in the post-operative period are deemed ready to begin therapy, patients will receive 8 cycles of mFOLFOX6 in addition to Nivolumab and FVP-CV301 boosters with the first two given on Day 0 and 14 and then every 4 weeks.
mFOLFOX6: Arm B will receive mFOLFOX6 every 2 weeks for 4 cycles. Once patients in the post-operative period are deemed ready to begin therapy, patients will then undergo another 8 cycles of mFOLFOX6.
MVA-BN-CV301: Arm B will receive MVA-BN-CV301 in 4 injections of 4 x 10(8) infectious units/0.5 mL given subcutaneously prior to the start of chemotherapy on days -28 and -14.
FPV-CV301: Arm B will receive FPV-CV301 in 1 dose of 1 x 10(9) infectious units/0.5 mL given subcutaneously concurrently with chemotherapy on days 0, 14, 28 and 42 pre-operatively, and FVP-CV301 boosters on day 0 and 14 and then every 4 weeks (day 42, 70, 98). After day 98, FVP-CV301 will then be administered every twelve weeks completing therapy at week 110.
Nivolumab: Nivolumab at a dose of 240 mg as a 30 minute IV infusion every 2 weeks until progression.
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60 years
n=5 Participants
|
61 years
n=7 Participants
|
61 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
9 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
ECOG Performance Status
ECOG = 0
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
ECOG Performance Status
ECOG = 1
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 yearsPopulation: In accordance with the Statistical Analysis Plan, the analysis population for the endpoint Overall survival was defined as all patients receive one dose of protocol therapy and are completely resected.
3-year Overall Survival (OS) rate is defined as the percentage of patients who are still alive at 3 years.
Outcome measures
| Measure |
Arm A - Control
n=7 Participants
mFOLFOX6 and Nivolumab every 2 weeks for 4 cycles. After neoadjuvant therapy, patients will be re-evaluated for surgical resection. Once patients in the post-operative period are deemed ready to begin therapy, patients in the control arm will then undergo another 8 cycles of mFOLFOX6 in addition to Nivolumab. After this, Nivolumab will be given every 4 weeks completing therapy at week 110.
mFOLFOX6: Arm A will receive mFOLFOX6 every 2 weeks for 4 cycles. Once patients in the post-operative period are deemed ready to begin therapy, patients in the control arm will then undergo another 8 cycles of mFOLFOX6.
Nivolumab: Nivolumab at a dose of 240 mg as a 30 minute IV infusion every 2 weeks until progression. Arm B will receive Nivolumab starting with the vaccinations. Arm A will begin the Nivolumab with the initiation mFOLFOX.
|
Arm B - Experimental
n=9 Participants
Two doses of Nivolumab and MVA-BN-CV301 will given 2 weeks apart (Days -28, -14), followed by four doses of Nivolumab plus FPV-CV301 given 2 weeks apart concurrently with mFOLFOX6 for 4 cycles. After neoadjuvant therapy, patients will be re-evaluated for surgical resection. Once patients in the post-operative period are deemed ready to begin therapy, patients will receive 8 cycles of mFOLFOX6 in addition to Nivolumab and FVP-CV301 boosters with the first two given on Day 0 and 14 and then every 4 weeks.
mFOLFOX6: Arm B will receive mFOLFOX6 every 2 weeks for 4 cycles. Once patients in the post-operative period are deemed ready to begin therapy, patients will then undergo another 8 cycles of mFOLFOX6.
MVA-BN-CV301: Arm B will receive MVA-BN-CV301 in 4 injections of 4 x 10(8) infectious units/0.5 mL given subcutaneously prior to the start of chemotherapy on days -28 and -14.
FPV-CV301: Arm B will receive FPV-CV301 in 1 dose of 1 x 10(9) infectious units/0.5 mL given subcutaneously concurrently with chemotherapy on days 0, 14, 28 and 42 pre-operatively, and FVP-CV301 boosters on day 0 and 14 and then every 4 weeks (day 42, 70, 98). After day 98, FVP-CV301 will then be administered every twelve weeks completing therapy at week 110.
Nivolumab: Nivolumab at a dose of 240 mg as a 30 minute IV infusion every 2 weeks until progression.
|
|---|---|---|
|
3-year Overall Survival (OS) Rate From Metastasectomy
|
100 Percentage of participants
|
100 Percentage of participants
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: In accordance with the Statistical Analysis Plan, the analysis population for the endpoint Recurrence free survival was defined as all patients receive one dose of protocol therapy and are completely resected.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) 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; Progressive Disease (PD) \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. The 3-year recurrence-free survival (RFS) rate is defined as the percentage of patients who have not experienced disease recurrence three years after treatment, as calculated using Kaplan-Meier survival analysis.
Outcome measures
| Measure |
Arm A - Control
n=7 Participants
mFOLFOX6 and Nivolumab every 2 weeks for 4 cycles. After neoadjuvant therapy, patients will be re-evaluated for surgical resection. Once patients in the post-operative period are deemed ready to begin therapy, patients in the control arm will then undergo another 8 cycles of mFOLFOX6 in addition to Nivolumab. After this, Nivolumab will be given every 4 weeks completing therapy at week 110.
mFOLFOX6: Arm A will receive mFOLFOX6 every 2 weeks for 4 cycles. Once patients in the post-operative period are deemed ready to begin therapy, patients in the control arm will then undergo another 8 cycles of mFOLFOX6.
Nivolumab: Nivolumab at a dose of 240 mg as a 30 minute IV infusion every 2 weeks until progression. Arm B will receive Nivolumab starting with the vaccinations. Arm A will begin the Nivolumab with the initiation mFOLFOX.
|
Arm B - Experimental
n=9 Participants
Two doses of Nivolumab and MVA-BN-CV301 will given 2 weeks apart (Days -28, -14), followed by four doses of Nivolumab plus FPV-CV301 given 2 weeks apart concurrently with mFOLFOX6 for 4 cycles. After neoadjuvant therapy, patients will be re-evaluated for surgical resection. Once patients in the post-operative period are deemed ready to begin therapy, patients will receive 8 cycles of mFOLFOX6 in addition to Nivolumab and FVP-CV301 boosters with the first two given on Day 0 and 14 and then every 4 weeks.
mFOLFOX6: Arm B will receive mFOLFOX6 every 2 weeks for 4 cycles. Once patients in the post-operative period are deemed ready to begin therapy, patients will then undergo another 8 cycles of mFOLFOX6.
MVA-BN-CV301: Arm B will receive MVA-BN-CV301 in 4 injections of 4 x 10(8) infectious units/0.5 mL given subcutaneously prior to the start of chemotherapy on days -28 and -14.
FPV-CV301: Arm B will receive FPV-CV301 in 1 dose of 1 x 10(9) infectious units/0.5 mL given subcutaneously concurrently with chemotherapy on days 0, 14, 28 and 42 pre-operatively, and FVP-CV301 boosters on day 0 and 14 and then every 4 weeks (day 42, 70, 98). After day 98, FVP-CV301 will then be administered every twelve weeks completing therapy at week 110.
Nivolumab: Nivolumab at a dose of 240 mg as a 30 minute IV infusion every 2 weeks until progression.
|
|---|---|---|
|
3-Year Recurrence Free Survival (RFS) Rate
|
53.6 Percentage of participants
|
61 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 57 monthsPopulation: In accordance with the Statistical Analysis Plan, the analysis population for the endpoints Overall Response Rate was defined as all patients receive one dose of protocol therapy and are completely resected.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) 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; Progressive Disease (PD) \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. ORR = CR +PR
Outcome measures
| Measure |
Arm A - Control
n=7 Participants
mFOLFOX6 and Nivolumab every 2 weeks for 4 cycles. After neoadjuvant therapy, patients will be re-evaluated for surgical resection. Once patients in the post-operative period are deemed ready to begin therapy, patients in the control arm will then undergo another 8 cycles of mFOLFOX6 in addition to Nivolumab. After this, Nivolumab will be given every 4 weeks completing therapy at week 110.
mFOLFOX6: Arm A will receive mFOLFOX6 every 2 weeks for 4 cycles. Once patients in the post-operative period are deemed ready to begin therapy, patients in the control arm will then undergo another 8 cycles of mFOLFOX6.
Nivolumab: Nivolumab at a dose of 240 mg as a 30 minute IV infusion every 2 weeks until progression. Arm B will receive Nivolumab starting with the vaccinations. Arm A will begin the Nivolumab with the initiation mFOLFOX.
|
Arm B - Experimental
n=9 Participants
Two doses of Nivolumab and MVA-BN-CV301 will given 2 weeks apart (Days -28, -14), followed by four doses of Nivolumab plus FPV-CV301 given 2 weeks apart concurrently with mFOLFOX6 for 4 cycles. After neoadjuvant therapy, patients will be re-evaluated for surgical resection. Once patients in the post-operative period are deemed ready to begin therapy, patients will receive 8 cycles of mFOLFOX6 in addition to Nivolumab and FVP-CV301 boosters with the first two given on Day 0 and 14 and then every 4 weeks.
mFOLFOX6: Arm B will receive mFOLFOX6 every 2 weeks for 4 cycles. Once patients in the post-operative period are deemed ready to begin therapy, patients will then undergo another 8 cycles of mFOLFOX6.
MVA-BN-CV301: Arm B will receive MVA-BN-CV301 in 4 injections of 4 x 10(8) infectious units/0.5 mL given subcutaneously prior to the start of chemotherapy on days -28 and -14.
FPV-CV301: Arm B will receive FPV-CV301 in 1 dose of 1 x 10(9) infectious units/0.5 mL given subcutaneously concurrently with chemotherapy on days 0, 14, 28 and 42 pre-operatively, and FVP-CV301 boosters on day 0 and 14 and then every 4 weeks (day 42, 70, 98). After day 98, FVP-CV301 will then be administered every twelve weeks completing therapy at week 110.
Nivolumab: Nivolumab at a dose of 240 mg as a 30 minute IV infusion every 2 weeks until progression.
|
|---|---|---|
|
Overall Response Rate (ORR)
|
57.14 Percentage of participants
|
100 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 57 monthsPopulation: In accordance with the Statistical Analysis Plan, the analysis population for the endpoints Percentage of patients amenable to complete resection/ablation was defined as all patients who experience a recurrence after surgery.
Compare the percentage of patients amenable to complete resection/ablation between the experimental and control treatment groups in patients who experience a recurrence after surgery
Outcome measures
| Measure |
Arm A - Control
n=5 Participants
mFOLFOX6 and Nivolumab every 2 weeks for 4 cycles. After neoadjuvant therapy, patients will be re-evaluated for surgical resection. Once patients in the post-operative period are deemed ready to begin therapy, patients in the control arm will then undergo another 8 cycles of mFOLFOX6 in addition to Nivolumab. After this, Nivolumab will be given every 4 weeks completing therapy at week 110.
mFOLFOX6: Arm A will receive mFOLFOX6 every 2 weeks for 4 cycles. Once patients in the post-operative period are deemed ready to begin therapy, patients in the control arm will then undergo another 8 cycles of mFOLFOX6.
Nivolumab: Nivolumab at a dose of 240 mg as a 30 minute IV infusion every 2 weeks until progression. Arm B will receive Nivolumab starting with the vaccinations. Arm A will begin the Nivolumab with the initiation mFOLFOX.
|
Arm B - Experimental
n=3 Participants
Two doses of Nivolumab and MVA-BN-CV301 will given 2 weeks apart (Days -28, -14), followed by four doses of Nivolumab plus FPV-CV301 given 2 weeks apart concurrently with mFOLFOX6 for 4 cycles. After neoadjuvant therapy, patients will be re-evaluated for surgical resection. Once patients in the post-operative period are deemed ready to begin therapy, patients will receive 8 cycles of mFOLFOX6 in addition to Nivolumab and FVP-CV301 boosters with the first two given on Day 0 and 14 and then every 4 weeks.
mFOLFOX6: Arm B will receive mFOLFOX6 every 2 weeks for 4 cycles. Once patients in the post-operative period are deemed ready to begin therapy, patients will then undergo another 8 cycles of mFOLFOX6.
MVA-BN-CV301: Arm B will receive MVA-BN-CV301 in 4 injections of 4 x 10(8) infectious units/0.5 mL given subcutaneously prior to the start of chemotherapy on days -28 and -14.
FPV-CV301: Arm B will receive FPV-CV301 in 1 dose of 1 x 10(9) infectious units/0.5 mL given subcutaneously concurrently with chemotherapy on days 0, 14, 28 and 42 pre-operatively, and FVP-CV301 boosters on day 0 and 14 and then every 4 weeks (day 42, 70, 98). After day 98, FVP-CV301 will then be administered every twelve weeks completing therapy at week 110.
Nivolumab: Nivolumab at a dose of 240 mg as a 30 minute IV infusion every 2 weeks until progression.
|
|---|---|---|
|
Patients Amenable to Complete Resection/Ablation
|
40 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 6 monthsPopulation: In accordance with the Statistical Analysis Plan, the analysis population for the endpoints Perioperative Surgical Outcomes was defined as all patients receive one dose of protocol therapy and are completely resected.
The Clavien-Dindo classification will be used for grading the severity of postoperative complications. It provides a standardized way to report and compare surgical outcomes, based on the therapy required to treat a complication. It grades from 1 to 5 where 1= Any deviation from normal postoperative course without need for pharmacological, surgical, endoscopic, or radiological interventions. Acceptable treatments: antiemetics, antipyretics, analgesics, physiotherapy, wound dressings. 2 = Requires pharmacological treatment with drugs other than those allowed for Grade 1. Includes blood transfusions, antibiotics and total parenteral nutrition (TPN). 3 = Requiring surgical, endoscoptic or radiological intervention. 3a = Intervention under regional/local anesthesia. 3b = Intervention under general anesthesia. 4= Life-threatening complication requiring intensive care/intensive care unit management.4a= Single organ dysfunction. 4b= Multi-organ dysfunction. 5 = Patient demise.
Outcome measures
| Measure |
Arm A - Control
n=7 Participants
mFOLFOX6 and Nivolumab every 2 weeks for 4 cycles. After neoadjuvant therapy, patients will be re-evaluated for surgical resection. Once patients in the post-operative period are deemed ready to begin therapy, patients in the control arm will then undergo another 8 cycles of mFOLFOX6 in addition to Nivolumab. After this, Nivolumab will be given every 4 weeks completing therapy at week 110.
mFOLFOX6: Arm A will receive mFOLFOX6 every 2 weeks for 4 cycles. Once patients in the post-operative period are deemed ready to begin therapy, patients in the control arm will then undergo another 8 cycles of mFOLFOX6.
Nivolumab: Nivolumab at a dose of 240 mg as a 30 minute IV infusion every 2 weeks until progression. Arm B will receive Nivolumab starting with the vaccinations. Arm A will begin the Nivolumab with the initiation mFOLFOX.
|
Arm B - Experimental
n=9 Participants
Two doses of Nivolumab and MVA-BN-CV301 will given 2 weeks apart (Days -28, -14), followed by four doses of Nivolumab plus FPV-CV301 given 2 weeks apart concurrently with mFOLFOX6 for 4 cycles. After neoadjuvant therapy, patients will be re-evaluated for surgical resection. Once patients in the post-operative period are deemed ready to begin therapy, patients will receive 8 cycles of mFOLFOX6 in addition to Nivolumab and FVP-CV301 boosters with the first two given on Day 0 and 14 and then every 4 weeks.
mFOLFOX6: Arm B will receive mFOLFOX6 every 2 weeks for 4 cycles. Once patients in the post-operative period are deemed ready to begin therapy, patients will then undergo another 8 cycles of mFOLFOX6.
MVA-BN-CV301: Arm B will receive MVA-BN-CV301 in 4 injections of 4 x 10(8) infectious units/0.5 mL given subcutaneously prior to the start of chemotherapy on days -28 and -14.
FPV-CV301: Arm B will receive FPV-CV301 in 1 dose of 1 x 10(9) infectious units/0.5 mL given subcutaneously concurrently with chemotherapy on days 0, 14, 28 and 42 pre-operatively, and FVP-CV301 boosters on day 0 and 14 and then every 4 weeks (day 42, 70, 98). After day 98, FVP-CV301 will then be administered every twelve weeks completing therapy at week 110.
Nivolumab: Nivolumab at a dose of 240 mg as a 30 minute IV infusion every 2 weeks until progression.
|
|---|---|---|
|
Perioperative Surgical Outcomes
Grade = 1
|
4 Participants
|
4 Participants
|
|
Perioperative Surgical Outcomes
Grade = 2
|
1 Participants
|
2 Participants
|
|
Perioperative Surgical Outcomes
Grade = 3
|
0 Participants
|
1 Participants
|
|
Perioperative Surgical Outcomes
Grade = 3b
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 3 years3-Year OS (Overall Survival) rate is defined as the percentage of patients who are still alive at 3 years.
Outcome measures
| Measure |
Arm A - Control
n=8 Participants
mFOLFOX6 and Nivolumab every 2 weeks for 4 cycles. After neoadjuvant therapy, patients will be re-evaluated for surgical resection. Once patients in the post-operative period are deemed ready to begin therapy, patients in the control arm will then undergo another 8 cycles of mFOLFOX6 in addition to Nivolumab. After this, Nivolumab will be given every 4 weeks completing therapy at week 110.
mFOLFOX6: Arm A will receive mFOLFOX6 every 2 weeks for 4 cycles. Once patients in the post-operative period are deemed ready to begin therapy, patients in the control arm will then undergo another 8 cycles of mFOLFOX6.
Nivolumab: Nivolumab at a dose of 240 mg as a 30 minute IV infusion every 2 weeks until progression. Arm B will receive Nivolumab starting with the vaccinations. Arm A will begin the Nivolumab with the initiation mFOLFOX.
|
Arm B - Experimental
n=9 Participants
Two doses of Nivolumab and MVA-BN-CV301 will given 2 weeks apart (Days -28, -14), followed by four doses of Nivolumab plus FPV-CV301 given 2 weeks apart concurrently with mFOLFOX6 for 4 cycles. After neoadjuvant therapy, patients will be re-evaluated for surgical resection. Once patients in the post-operative period are deemed ready to begin therapy, patients will receive 8 cycles of mFOLFOX6 in addition to Nivolumab and FVP-CV301 boosters with the first two given on Day 0 and 14 and then every 4 weeks.
mFOLFOX6: Arm B will receive mFOLFOX6 every 2 weeks for 4 cycles. Once patients in the post-operative period are deemed ready to begin therapy, patients will then undergo another 8 cycles of mFOLFOX6.
MVA-BN-CV301: Arm B will receive MVA-BN-CV301 in 4 injections of 4 x 10(8) infectious units/0.5 mL given subcutaneously prior to the start of chemotherapy on days -28 and -14.
FPV-CV301: Arm B will receive FPV-CV301 in 1 dose of 1 x 10(9) infectious units/0.5 mL given subcutaneously concurrently with chemotherapy on days 0, 14, 28 and 42 pre-operatively, and FVP-CV301 boosters on day 0 and 14 and then every 4 weeks (day 42, 70, 98). After day 98, FVP-CV301 will then be administered every twelve weeks completing therapy at week 110.
Nivolumab: Nivolumab at a dose of 240 mg as a 30 minute IV infusion every 2 weeks until progression.
|
|---|---|---|
|
3-Year Overall Survival (OS) Rate From Registration
|
100 Percentage of participants
|
100 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 6 monthsPopulation: In accordance with the Statistical Analysis Plan, the analysis population for the endpoints pathologic response was defined as all patients receive one dose of protocol therapy and are completely resected.
Compare the pathologic response rate to neoadjuvant therapy in resected tumor tissue between the experimental and control groups. Pathologic Response Rate refers to the percentage of patients whose tumors show a specific level of response after it has been surgically removed.
Outcome measures
| Measure |
Arm A - Control
n=7 Participants
mFOLFOX6 and Nivolumab every 2 weeks for 4 cycles. After neoadjuvant therapy, patients will be re-evaluated for surgical resection. Once patients in the post-operative period are deemed ready to begin therapy, patients in the control arm will then undergo another 8 cycles of mFOLFOX6 in addition to Nivolumab. After this, Nivolumab will be given every 4 weeks completing therapy at week 110.
mFOLFOX6: Arm A will receive mFOLFOX6 every 2 weeks for 4 cycles. Once patients in the post-operative period are deemed ready to begin therapy, patients in the control arm will then undergo another 8 cycles of mFOLFOX6.
Nivolumab: Nivolumab at a dose of 240 mg as a 30 minute IV infusion every 2 weeks until progression. Arm B will receive Nivolumab starting with the vaccinations. Arm A will begin the Nivolumab with the initiation mFOLFOX.
|
Arm B - Experimental
n=9 Participants
Two doses of Nivolumab and MVA-BN-CV301 will given 2 weeks apart (Days -28, -14), followed by four doses of Nivolumab plus FPV-CV301 given 2 weeks apart concurrently with mFOLFOX6 for 4 cycles. After neoadjuvant therapy, patients will be re-evaluated for surgical resection. Once patients in the post-operative period are deemed ready to begin therapy, patients will receive 8 cycles of mFOLFOX6 in addition to Nivolumab and FVP-CV301 boosters with the first two given on Day 0 and 14 and then every 4 weeks.
mFOLFOX6: Arm B will receive mFOLFOX6 every 2 weeks for 4 cycles. Once patients in the post-operative period are deemed ready to begin therapy, patients will then undergo another 8 cycles of mFOLFOX6.
MVA-BN-CV301: Arm B will receive MVA-BN-CV301 in 4 injections of 4 x 10(8) infectious units/0.5 mL given subcutaneously prior to the start of chemotherapy on days -28 and -14.
FPV-CV301: Arm B will receive FPV-CV301 in 1 dose of 1 x 10(9) infectious units/0.5 mL given subcutaneously concurrently with chemotherapy on days 0, 14, 28 and 42 pre-operatively, and FVP-CV301 boosters on day 0 and 14 and then every 4 weeks (day 42, 70, 98). After day 98, FVP-CV301 will then be administered every twelve weeks completing therapy at week 110.
Nivolumab: Nivolumab at a dose of 240 mg as a 30 minute IV infusion every 2 weeks until progression.
|
|---|---|---|
|
Pathologic Response Rate
|
71.4 Percentage of participants
|
100 Percentage of participants
|
Adverse Events
Arm A - Control
Serious events: 6 serious events
Other events: 8 other events
Deaths: 0 deaths
Arm B - Experimental
Serious events: 5 serious events
Other events: 9 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Arm A - Control
n=8 participants at risk
mFOLFOX6 and Nivolumab every 2 weeks for 4 cycles. After neoadjuvant therapy, patients will be re-evaluated for surgical resection. Once patients in the post-operative period are deemed ready to begin therapy, patients in the control arm will then undergo another 8 cycles of mFOLFOX6 in addition to Nivolumab. After this, Nivolumab will be given every 4 weeks completing therapy at week 110.
mFOLFOX6: Arm A will receive mFOLFOX6 every 2 weeks for 4 cycles. Once patients in the post-operative period are deemed ready to begin therapy, patients in the control arm will then undergo another 8 cycles of mFOLFOX6.
Nivolumab: Nivolumab at a dose of 240 mg as a 30 minute IV infusion every 2 weeks until progression. Arm B will receive Nivolumab starting with the vaccinations. Arm A will begin the Nivolumab with the initiation mFOLFOX.
|
Arm B - Experimental
n=9 participants at risk
Two doses of Nivolumab and MVA-BN-CV301 will given 2 weeks apart (Days -28, -14), followed by four doses of Nivolumab plus FPV-CV301 given 2 weeks apart concurrently with mFOLFOX6 for 4 cycles. After neoadjuvant therapy, patients will be re-evaluated for surgical resection. Once patients in the post-operative period are deemed ready to begin therapy, patients will receive 8 cycles of mFOLFOX6 in addition to Nivolumab and FVP-CV301 boosters with the first two given on Day 0 and 14 and then every 4 weeks.
mFOLFOX6: Arm B will receive mFOLFOX6 every 2 weeks for 4 cycles. Once patients in the post-operative period are deemed ready to begin therapy, patients will then undergo another 8 cycles of mFOLFOX6.
MVA-BN-CV301: Arm B will receive MVA-BN-CV301 in 4 injections of 4 x 10(8) infectious units/0.5 mL given subcutaneously prior to the start of chemotherapy on days -28 and -14.
FPV-CV301: Arm B will receive FPV-CV301 in 1 dose of 1 x 10(9) infectious units/0.5 mL given subcutaneously concurrently with chemotherapy on days 0, 14, 28 and 42 pre-operatively, and FVP-CV301 boosters on day 0 and 14 and then every 4 weeks (day 42, 70, 98). After day 98, FVP-CV301 will then be administered every twelve weeks completing therapy at week 110.
Nivolumab: Nivolumab at a dose of 240 mg as a 30 minute IV infusion every 2 weeks until progression.
|
|---|---|---|
|
Infections and infestations
ABDOMINAL INFECTION
|
12.5%
1/8 • Number of events 1 • Up to 5 years
|
0.00%
0/9 • Up to 5 years
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
12.5%
1/8 • Number of events 1 • Up to 5 years
|
0.00%
0/9 • Up to 5 years
|
|
Gastrointestinal disorders
COLONIC OBSTRUCTION
|
12.5%
1/8 • Number of events 1 • Up to 5 years
|
11.1%
1/9 • Number of events 2 • Up to 5 years
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
12.5%
1/8 • Number of events 1 • Up to 5 years
|
0.00%
0/9 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
12.5%
1/8 • Number of events 1 • Up to 5 years
|
0.00%
0/9 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
12.5%
1/8 • Number of events 1 • Up to 5 years
|
0.00%
0/9 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
12.5%
1/8 • Number of events 1 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - OTHER, SPECIFY
|
12.5%
1/8 • Number of events 1 • Up to 5 years
|
0.00%
0/9 • Up to 5 years
|
|
Infections and infestations
SEPSIS
|
12.5%
1/8 • Number of events 1 • Up to 5 years
|
11.1%
1/9 • Number of events 3 • Up to 5 years
|
|
Surgical and medical procedures
SURGICAL AND MEDICAL PROCEDURES - OTHER, SPECIFY
|
12.5%
1/8 • Number of events 1 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
|
Vascular disorders
THROMBOEMBOLIC EVENT
|
12.5%
1/8 • Number of events 1 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
|
Vascular disorders
VASCULAR DISORDERS - OTHER, SPECIFY
|
12.5%
1/8 • Number of events 1 • Up to 5 years
|
0.00%
0/9 • Up to 5 years
|
|
Endocrine disorders
ADRENAL INSUFFICIENCY
|
0.00%
0/8 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
|
Infections and infestations
APPENDICITIS
|
0.00%
0/8 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/8 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
|
Metabolism and nutrition disorders
HYPOKALEMIA
|
0.00%
0/8 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
|
Vascular disorders
HYPOTENSION
|
0.00%
0/8 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
|
General disorders
INFUSION RELATED REACTION
|
0.00%
0/8 • Up to 5 years
|
11.1%
1/9 • Number of events 4 • Up to 5 years
|
|
Cardiac disorders
PERICARDIAL EFFUSION
|
0.00%
0/8 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
Other adverse events
| Measure |
Arm A - Control
n=8 participants at risk
mFOLFOX6 and Nivolumab every 2 weeks for 4 cycles. After neoadjuvant therapy, patients will be re-evaluated for surgical resection. Once patients in the post-operative period are deemed ready to begin therapy, patients in the control arm will then undergo another 8 cycles of mFOLFOX6 in addition to Nivolumab. After this, Nivolumab will be given every 4 weeks completing therapy at week 110.
mFOLFOX6: Arm A will receive mFOLFOX6 every 2 weeks for 4 cycles. Once patients in the post-operative period are deemed ready to begin therapy, patients in the control arm will then undergo another 8 cycles of mFOLFOX6.
Nivolumab: Nivolumab at a dose of 240 mg as a 30 minute IV infusion every 2 weeks until progression. Arm B will receive Nivolumab starting with the vaccinations. Arm A will begin the Nivolumab with the initiation mFOLFOX.
|
Arm B - Experimental
n=9 participants at risk
Two doses of Nivolumab and MVA-BN-CV301 will given 2 weeks apart (Days -28, -14), followed by four doses of Nivolumab plus FPV-CV301 given 2 weeks apart concurrently with mFOLFOX6 for 4 cycles. After neoadjuvant therapy, patients will be re-evaluated for surgical resection. Once patients in the post-operative period are deemed ready to begin therapy, patients will receive 8 cycles of mFOLFOX6 in addition to Nivolumab and FVP-CV301 boosters with the first two given on Day 0 and 14 and then every 4 weeks.
mFOLFOX6: Arm B will receive mFOLFOX6 every 2 weeks for 4 cycles. Once patients in the post-operative period are deemed ready to begin therapy, patients will then undergo another 8 cycles of mFOLFOX6.
MVA-BN-CV301: Arm B will receive MVA-BN-CV301 in 4 injections of 4 x 10(8) infectious units/0.5 mL given subcutaneously prior to the start of chemotherapy on days -28 and -14.
FPV-CV301: Arm B will receive FPV-CV301 in 1 dose of 1 x 10(9) infectious units/0.5 mL given subcutaneously concurrently with chemotherapy on days 0, 14, 28 and 42 pre-operatively, and FVP-CV301 boosters on day 0 and 14 and then every 4 weeks (day 42, 70, 98). After day 98, FVP-CV301 will then be administered every twelve weeks completing therapy at week 110.
Nivolumab: Nivolumab at a dose of 240 mg as a 30 minute IV infusion every 2 weeks until progression.
|
|---|---|---|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
50.0%
4/8 • Number of events 4 • Up to 5 years
|
44.4%
4/9 • Number of events 6 • Up to 5 years
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
12.5%
1/8 • Number of events 1 • Up to 5 years
|
0.00%
0/9 • Up to 5 years
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
62.5%
5/8 • Number of events 13 • Up to 5 years
|
77.8%
7/9 • Number of events 33 • Up to 5 years
|
|
Investigations
ALKALINE PHOSPHATASE INCREASED
|
50.0%
4/8 • Number of events 6 • Up to 5 years
|
66.7%
6/9 • Number of events 18 • Up to 5 years
|
|
Blood and lymphatic system disorders
ANEMIA
|
75.0%
6/8 • Number of events 12 • Up to 5 years
|
66.7%
6/9 • Number of events 26 • Up to 5 years
|
|
Metabolism and nutrition disorders
ANOREXIA
|
25.0%
2/8 • Number of events 4 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
62.5%
5/8 • Number of events 10 • Up to 5 years
|
77.8%
7/9 • Number of events 31 • Up to 5 years
|
|
Gastrointestinal disorders
BLOATING
|
25.0%
2/8 • Number of events 2 • Up to 5 years
|
22.2%
2/9 • Number of events 3 • Up to 5 years
|
|
Blood and lymphatic system disorders
BLOOD AND LYMPHATIC SYSTEM DISORDERS - OTHER, SPECIFY
|
12.5%
1/8 • Number of events 1 • Up to 5 years
|
22.2%
2/9 • Number of events 3 • Up to 5 years
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
25.0%
2/8 • Number of events 9 • Up to 5 years
|
11.1%
1/9 • Number of events 5 • Up to 5 years
|
|
Eye disorders
BLURRED VISION
|
12.5%
1/8 • Number of events 1 • Up to 5 years
|
22.2%
2/9 • Number of events 2 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
12.5%
1/8 • Number of events 1 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
|
Injury, poisoning and procedural complications
BRUISING
|
12.5%
1/8 • Number of events 1 • Up to 5 years
|
0.00%
0/9 • Up to 5 years
|
|
General disorders
CHILLS
|
25.0%
2/8 • Number of events 2 • Up to 5 years
|
44.4%
4/9 • Number of events 6 • Up to 5 years
|
|
Nervous system disorders
CONCENTRATION IMPAIRMENT
|
12.5%
1/8 • Number of events 1 • Up to 5 years
|
0.00%
0/9 • Up to 5 years
|
|
Gastrointestinal disorders
CONSTIPATION
|
75.0%
6/8 • Number of events 6 • Up to 5 years
|
22.2%
2/9 • Number of events 4 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
25.0%
2/8 • Number of events 2 • Up to 5 years
|
22.2%
2/9 • Number of events 3 • Up to 5 years
|
|
Investigations
CREATININE INCREASED
|
37.5%
3/8 • Number of events 7 • Up to 5 years
|
11.1%
1/9 • Number of events 3 • Up to 5 years
|
|
Gastrointestinal disorders
DIARRHEA
|
62.5%
5/8 • Number of events 6 • Up to 5 years
|
88.9%
8/9 • Number of events 14 • Up to 5 years
|
|
Nervous system disorders
DIZZINESS
|
12.5%
1/8 • Number of events 1 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
DRY MOUTH
|
37.5%
3/8 • Number of events 3 • Up to 5 years
|
22.2%
2/9 • Number of events 3 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
12.5%
1/8 • Number of events 1 • Up to 5 years
|
0.00%
0/9 • Up to 5 years
|
|
Nervous system disorders
DYSARTHRIA
|
12.5%
1/8 • Number of events 1 • Up to 5 years
|
0.00%
0/9 • Up to 5 years
|
|
Nervous system disorders
DYSGEUSIA
|
12.5%
1/8 • Number of events 2 • Up to 5 years
|
44.4%
4/9 • Number of events 7 • Up to 5 years
|
|
Gastrointestinal disorders
DYSPEPSIA
|
12.5%
1/8 • Number of events 1 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA
|
12.5%
1/8 • Number of events 1 • Up to 5 years
|
22.2%
2/9 • Number of events 2 • Up to 5 years
|
|
General disorders
EDEMA LIMBS
|
25.0%
2/8 • Number of events 3 • Up to 5 years
|
22.2%
2/9 • Number of events 2 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
25.0%
2/8 • Number of events 2 • Up to 5 years
|
0.00%
0/9 • Up to 5 years
|
|
General disorders
FATIGUE
|
62.5%
5/8 • Number of events 8 • Up to 5 years
|
77.8%
7/9 • Number of events 17 • Up to 5 years
|
|
General disorders
FEVER
|
37.5%
3/8 • Number of events 3 • Up to 5 years
|
33.3%
3/9 • Number of events 7 • Up to 5 years
|
|
Gastrointestinal disorders
GASTROESOPHAGEAL REFLUX DISEASE
|
37.5%
3/8 • Number of events 4 • Up to 5 years
|
44.4%
4/9 • Number of events 4 • Up to 5 years
|
|
Gastrointestinal disorders
GASTROINTESTINAL DISORDERS - OTHER, SPECIFY
|
12.5%
1/8 • Number of events 2 • Up to 5 years
|
22.2%
2/9 • Number of events 3 • Up to 5 years
|
|
Gastrointestinal disorders
GASTROINTESTINAL PAIN
|
12.5%
1/8 • Number of events 1 • Up to 5 years
|
0.00%
0/9 • Up to 5 years
|
|
Nervous system disorders
HEADACHE
|
12.5%
1/8 • Number of events 3 • Up to 5 years
|
33.3%
3/9 • Number of events 8 • Up to 5 years
|
|
Vascular disorders
HEMATOMA
|
12.5%
1/8 • Number of events 2 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
|
Renal and urinary disorders
HEMATURIA
|
25.0%
2/8 • Number of events 2 • Up to 5 years
|
0.00%
0/9 • Up to 5 years
|
|
Gastrointestinal disorders
HEMORRHOIDS
|
12.5%
1/8 • Number of events 1 • Up to 5 years
|
0.00%
0/9 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
HICCUPS
|
12.5%
1/8 • Number of events 1 • Up to 5 years
|
11.1%
1/9 • Number of events 2 • Up to 5 years
|
|
Metabolism and nutrition disorders
HYPERGLYCEMIA
|
37.5%
3/8 • Number of events 14 • Up to 5 years
|
77.8%
7/9 • Number of events 27 • Up to 5 years
|
|
Metabolism and nutrition disorders
HYPERKALEMIA
|
25.0%
2/8 • Number of events 4 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
|
Metabolism and nutrition disorders
HYPERNATREMIA
|
37.5%
3/8 • Number of events 4 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
|
Vascular disorders
HYPERTENSION
|
50.0%
4/8 • Number of events 9 • Up to 5 years
|
55.6%
5/9 • Number of events 15 • Up to 5 years
|
|
Metabolism and nutrition disorders
HYPOALBUMINEMIA
|
50.0%
4/8 • Number of events 9 • Up to 5 years
|
44.4%
4/9 • Number of events 11 • Up to 5 years
|
|
Metabolism and nutrition disorders
HYPOCALCEMIA
|
50.0%
4/8 • Number of events 12 • Up to 5 years
|
44.4%
4/9 • Number of events 12 • Up to 5 years
|
|
Metabolism and nutrition disorders
HYPOGLYCEMIA
|
25.0%
2/8 • Number of events 3 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
|
Metabolism and nutrition disorders
HYPOKALEMIA
|
37.5%
3/8 • Number of events 3 • Up to 5 years
|
44.4%
4/9 • Number of events 9 • Up to 5 years
|
|
Metabolism and nutrition disorders
HYPOMAGNESEMIA
|
50.0%
4/8 • Number of events 5 • Up to 5 years
|
44.4%
4/9 • Number of events 9 • Up to 5 years
|
|
Metabolism and nutrition disorders
HYPONATREMIA
|
50.0%
4/8 • Number of events 6 • Up to 5 years
|
66.7%
6/9 • Number of events 12 • Up to 5 years
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATEMIA
|
37.5%
3/8 • Number of events 6 • Up to 5 years
|
33.3%
3/9 • Number of events 6 • Up to 5 years
|
|
Vascular disorders
HYPOTENSION
|
25.0%
2/8 • Number of events 2 • Up to 5 years
|
22.2%
2/9 • Number of events 3 • Up to 5 years
|
|
Endocrine disorders
HYPOTHYROIDISM
|
12.5%
1/8 • Number of events 1 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
|
Immune system disorders
IMMUNE SYSTEM DISORDERS - OTHER, SPECIFY
|
12.5%
1/8 • Number of events 1 • Up to 5 years
|
0.00%
0/9 • Up to 5 years
|
|
Investigations
INR INCREASED
|
12.5%
1/8 • Number of events 1 • Up to 5 years
|
0.00%
0/9 • Up to 5 years
|
|
Psychiatric disorders
INSOMNIA
|
12.5%
1/8 • Number of events 1 • Up to 5 years
|
44.4%
4/9 • Number of events 6 • Up to 5 years
|
|
Investigations
INVESTIGATIONS - OTHER, SPECIFY
|
25.0%
2/8 • Number of events 2 • Up to 5 years
|
33.3%
3/9 • Number of events 4 • Up to 5 years
|
|
Investigations
LIPASE INCREASED
|
87.5%
7/8 • Number of events 20 • Up to 5 years
|
55.6%
5/9 • Number of events 26 • Up to 5 years
|
|
Investigations
LYMPHOCYTE COUNT DECREASED
|
50.0%
4/8 • Number of events 12 • Up to 5 years
|
55.6%
5/9 • Number of events 20 • Up to 5 years
|
|
Gastrointestinal disorders
MUCOSITIS ORAL
|
25.0%
2/8 • Number of events 4 • Up to 5 years
|
33.3%
3/9 • Number of events 4 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDER - OTHER, SPECIFY
|
12.5%
1/8 • Number of events 1 • Up to 5 years
|
33.3%
3/9 • Number of events 3 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
12.5%
1/8 • Number of events 1 • Up to 5 years
|
22.2%
2/9 • Number of events 2 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
12.5%
1/8 • Number of events 2 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
NAUSEA
|
37.5%
3/8 • Number of events 4 • Up to 5 years
|
66.7%
6/9 • Number of events 17 • Up to 5 years
|
|
Nervous system disorders
NERVOUS SYSTEM DISORDERS - OTHER, SPECIFY
|
12.5%
1/8 • Number of events 1 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
75.0%
6/8 • Number of events 13 • Up to 5 years
|
77.8%
7/9 • Number of events 18 • Up to 5 years
|
|
Gastrointestinal disorders
ORAL PAIN
|
12.5%
1/8 • Number of events 1 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
|
General disorders
PAIN
|
25.0%
2/8 • Number of events 3 • Up to 5 years
|
33.3%
3/9 • Number of events 3 • Up to 5 years
|
|
Nervous system disorders
PARESTHESIA
|
12.5%
1/8 • Number of events 1 • Up to 5 years
|
22.2%
2/9 • Number of events 3 • Up to 5 years
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
|
75.0%
6/8 • Number of events 9 • Up to 5 years
|
100.0%
9/9 • Number of events 21 • Up to 5 years
|
|
Eye disorders
PHOTOPHOBIA
|
12.5%
1/8 • Number of events 1 • Up to 5 years
|
0.00%
0/9 • Up to 5 years
|
|
Investigations
PLATELET COUNT DECREASED
|
75.0%
6/8 • Number of events 16 • Up to 5 years
|
66.7%
6/9 • Number of events 11 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
12.5%
1/8 • Number of events 4 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
12.5%
1/8 • Number of events 1 • Up to 5 years
|
33.3%
3/9 • Number of events 5 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
50.0%
4/8 • Number of events 8 • Up to 5 years
|
33.3%
3/9 • Number of events 5 • Up to 5 years
|
|
Gastrointestinal disorders
RECTAL HEMORRHAGE
|
12.5%
1/8 • Number of events 1 • Up to 5 years
|
0.00%
0/9 • Up to 5 years
|
|
Investigations
SERUM AMYLASE INCREASED
|
87.5%
7/8 • Number of events 11 • Up to 5 years
|
44.4%
4/9 • Number of events 12 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
SKIN AND SUBCUTANEOUS TISSUE DISORDERS - OTHER, SPECIFY
|
37.5%
3/8 • Number of events 5 • Up to 5 years
|
22.2%
2/9 • Number of events 7 • Up to 5 years
|
|
Vascular disorders
THROMBOEMBOLIC EVENT
|
37.5%
3/8 • Number of events 4 • Up to 5 years
|
0.00%
0/9 • Up to 5 years
|
|
Renal and urinary disorders
URINARY FREQUENCY
|
25.0%
2/8 • Number of events 2 • Up to 5 years
|
0.00%
0/9 • Up to 5 years
|
|
Renal and urinary disorders
URINARY RETENTION
|
12.5%
1/8 • Number of events 1 • Up to 5 years
|
0.00%
0/9 • Up to 5 years
|
|
Infections and infestations
URINARY TRACT INFECTION
|
12.5%
1/8 • Number of events 1 • Up to 5 years
|
0.00%
0/9 • Up to 5 years
|
|
Renal and urinary disorders
URINARY TRACT PAIN
|
12.5%
1/8 • Number of events 2 • Up to 5 years
|
0.00%
0/9 • Up to 5 years
|
|
Gastrointestinal disorders
VOMITING
|
50.0%
4/8 • Number of events 4 • Up to 5 years
|
33.3%
3/9 • Number of events 3 • Up to 5 years
|
|
Investigations
WEIGHT GAIN
|
12.5%
1/8 • Number of events 1 • Up to 5 years
|
0.00%
0/9 • Up to 5 years
|
|
Investigations
WEIGHT LOSS
|
12.5%
1/8 • Number of events 3 • Up to 5 years
|
11.1%
1/9 • Number of events 2 • Up to 5 years
|
|
Investigations
WHITE BLOOD CELL DECREASED
|
50.0%
4/8 • Number of events 10 • Up to 5 years
|
55.6%
5/9 • Number of events 18 • Up to 5 years
|
|
Endocrine disorders
ADRENAL INSUFFICIENCY
|
0.00%
0/8 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
0.00%
0/8 • Up to 5 years
|
33.3%
3/9 • Number of events 3 • Up to 5 years
|
|
Psychiatric disorders
ANXIETY
|
0.00%
0/8 • Up to 5 years
|
22.2%
2/9 • Number of events 4 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.00%
0/8 • Up to 5 years
|
22.2%
2/9 • Number of events 3 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS
|
0.00%
0/8 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/8 • Up to 5 years
|
33.3%
3/9 • Number of events 4 • Up to 5 years
|
|
Renal and urinary disorders
BLADDER SPASM
|
0.00%
0/8 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
|
Cardiac disorders
CARDIAC DISORDERS - OTHER, SPECIFY
|
0.00%
0/8 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
|
Psychiatric disorders
CONFUSION
|
0.00%
0/8 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
|
Investigations
CPK INCREASED
|
0.00%
0/8 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
|
Psychiatric disorders
DELIRIUM
|
0.00%
0/8 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
|
Psychiatric disorders
DEPRESSION
|
0.00%
0/8 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
|
Eye disorders
DRY EYE
|
0.00%
0/8 • Up to 5 years
|
22.2%
2/9 • Number of events 2 • Up to 5 years
|
|
Gastrointestinal disorders
DYSPHAGIA
|
0.00%
0/8 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
ERYTHRODERMA
|
0.00%
0/8 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
|
Eye disorders
EYE DISORDERS - OTHER, SPECIFY
|
0.00%
0/8 • Up to 5 years
|
22.2%
2/9 • Number of events 2 • Up to 5 years
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
0.00%
0/8 • Up to 5 years
|
11.1%
1/9 • Number of events 2 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
FLANK PAIN
|
0.00%
0/8 • Up to 5 years
|
11.1%
1/9 • Number of events 2 • Up to 5 years
|
|
General disorders
FLU LIKE SYMPTOMS
|
0.00%
0/8 • Up to 5 years
|
22.2%
2/9 • Number of events 3 • Up to 5 years
|
|
Vascular disorders
FLUSHING
|
0.00%
0/8 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
|
General disorders
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS - OTHER, SPECIFY
|
0.00%
0/8 • Up to 5 years
|
33.3%
3/9 • Number of events 10 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
GENERALIZED MUSCLE WEAKNESS
|
0.00%
0/8 • Up to 5 years
|
11.1%
1/9 • Number of events 2 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
HOARSENESS
|
0.00%
0/8 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
|
Vascular disorders
HOT FLASHES
|
0.00%
0/8 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
|
Metabolism and nutrition disorders
HYPERCALCEMIA
|
0.00%
0/8 • Up to 5 years
|
33.3%
3/9 • Number of events 11 • Up to 5 years
|
|
Metabolism and nutrition disorders
HYPERMAGNESEMIA
|
0.00%
0/8 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
|
Endocrine disorders
HYPERTHYROIDISM
|
0.00%
0/8 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
|
General disorders
INFUSION RELATED REACTION
|
0.00%
0/8 • Up to 5 years
|
33.3%
3/9 • Number of events 5 • Up to 5 years
|
|
General disorders
INJECTION SITE REACTION
|
0.00%
0/8 • Up to 5 years
|
77.8%
7/9 • Number of events 10 • Up to 5 years
|
|
Injury, poisoning and procedural complications
INJURY, POISONING AND PROCEDURAL COMPLICATIONS - OTHER, SPECIFY
|
0.00%
0/8 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
|
Blood and lymphatic system disorders
LEUKOCYTOSIS
|
0.00%
0/8 • Up to 5 years
|
22.2%
2/9 • Number of events 2 • Up to 5 years
|
|
General disorders
MALAISE
|
0.00%
0/8 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS TRUNK
|
0.00%
0/8 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
NAIL LOSS
|
0.00%
0/8 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
OSTEOPOROSIS
|
0.00%
0/8 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.00%
0/8 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
PALMAR-PLANTAR ERYTHRODYSESTHESIA SYNDROME
|
0.00%
0/8 • Up to 5 years
|
11.1%
1/9 • Number of events 2 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
0.00%
0/8 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
RASH ACNEIFORM
|
0.00%
0/8 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - OTHER, SPECIFY
|
0.00%
0/8 • Up to 5 years
|
22.2%
2/9 • Number of events 2 • Up to 5 years
|
|
Cardiac disorders
SINUS BRADYCARDIA
|
0.00%
0/8 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
STOMACH PAIN
|
0.00%
0/8 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
|
Ear and labyrinth disorders
TINNITUS
|
0.00%
0/8 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
|
Nervous system disorders
TREMOR
|
0.00%
0/8 • Up to 5 years
|
11.1%
1/9 • Number of events 4 • Up to 5 years
|
|
Infections and infestations
UPPER RESPIRATORY INFECTION
|
0.00%
0/8 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
|
Renal and urinary disorders
URINARY INCONTINENCE
|
0.00%
0/8 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
0.00%
0/8 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
|
Vascular disorders
VASCULAR DISORDERS - OTHER, SPECIFY
|
0.00%
0/8 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
|
Injury, poisoning and procedural complications
WOUND COMPLICATION
|
0.00%
0/8 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place