Trial Outcomes & Findings for Safety Study of a Helper Peptide Vaccine Plus Adjuvant Combinations for the Treatment of Melanoma (NCT NCT02425306)
NCT ID: NCT02425306
Last Updated: 2023-10-30
Results Overview
Treatment-related adverse events, by CTCAE v4, Dose-limiting toxicities.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
48 participants
Primary outcome timeframe
30 days after administration of the last dose of 6MHP or cyclophosphamide
Results posted on
2023-10-30
Participant Flow
Open to accrual: May 12, 2015 Close to accrual: June 21, 2018 Participants all enrolled at an academic medical center.
Participant milestones
| Measure |
Arm A:6MHP + Montanide ISA-51
Part 1: 200 mcg of 6MHP emulsified in Montanide ISA-51 adjuvant will be administered on 1, 8, 15, 36, 57 and 78.
6MHP: 6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides
Montanide ISA-51: Montanide ISA-51 (Incomplete Freund's Adjuvant), local adjuvant
|
Arm B:6MHP + Montanide ISA-51 + Cyclophosphamide
Part 1: 200 mcg of 6MHP emulsified in Montanide ISA-51 adjuvant will be administered on 1, 8, 15, 36, 57 and 78. Cyclophosphamide (50 mg) will be taken orally once a day for 7 days followed by a 7 day rest period. This will be repeated for 5 cycles. Cycles will begin on the following days:
* Day -6 (Cycle 1)
* Day 8 (Cycle 2)
* Day 22 (Cycle 3)
* Day 36 (Cycle 4)
* Day 50 (Cycle 5)
6MHP: 6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides
Montanide ISA-51: Montanide ISA-51 (Incomplete Freund's Adjuvant), local adjuvant
Cyclophosphamide: Cyclophosphamide, systemic adjuvant
|
Arm C:6MHP + polyICLC + Montanide ISA-51
Part 1: 200 mcg of 6MHP plus 1 mg of polyICLC emulsified in Montanide ISA-51 adjuvant will be administered on 1, 8, 15, 36, 57 and 78.
6MHP: 6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides
Montanide ISA-51: Montanide ISA-51 (Incomplete Freund's Adjuvant), local adjuvant
polyICLC: polyICLC, local adjuvant
|
Arm D:6MHP + polyICLC + Montanide ISA-51 + Cyclophosphamide
Parts 1 and 2: 200 mcg of 6MHP plus 1 mg of polyICLC emulsified in Montanide ISA-51 adjuvant will be administered on 1, 8, 15, 36, 57 and 78. Cyclophosphamide (50 mg) will be taken orally once a day for 7 days followed by a 7 day rest period. This will be repeated for 5 cycles. Cycles will begin on the following days:
* Day -6 (Cycle 1)
* Day 8 (Cycle 2)
* Day 22 (Cycle 3)
* Day 36 (Cycle 4)
* Day 50 (Cycle 5)
6MHP: 6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides
Montanide ISA-51: Montanide ISA-51 (Incomplete Freund's Adjuvant), local adjuvant
polyICLC: polyICLC, local adjuvant
Cyclophosphamide: Cyclophosphamide, systemic adjuvant
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
7
|
6
|
32
|
|
Overall Study
COMPLETED
|
3
|
6
|
5
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
14
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety Study of a Helper Peptide Vaccine Plus Adjuvant Combinations for the Treatment of Melanoma
Baseline characteristics by cohort
| Measure |
Arm A:6MHP + Montanide ISA-51
n=3 Participants
Part 1: 200 mcg of 6MHP emulsified in Montanide ISA-51 adjuvant will be administered on 1, 8, 15, 36, 57 and 78.
6MHP: 6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides
Montanide ISA-51: Montanide ISA-51 (Incomplete Freund's Adjuvant), local adjuvant
|
Arm B:6MHP + Montanide ISA-51 + Cyclophosphamide
n=7 Participants
Part 1: 200 mcg of 6MHP emulsified in Montanide ISA-51 adjuvant will be administered on 1, 8, 15, 36, 57 and 78. Cyclophosphamide (50 mg) will be taken orally once a day for 7 days followed by a 7 day rest period. This will be repeated for 5 cycles. Cycles will begin on the following days:
* Day -6 (Cycle 1)
* Day 8 (Cycle 2)
* Day 22 (Cycle 3)
* Day 36 (Cycle 4)
* Day 50 (Cycle 5)
6MHP: 6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides
Montanide ISA-51: Montanide ISA-51 (Incomplete Freund's Adjuvant), local adjuvant
Cyclophosphamide: Cyclophosphamide, systemic adjuvant
|
Arm C:6MHP + polyICLC + Montanide ISA-51
n=6 Participants
Part 1: 200 mcg of 6MHP plus 1 mg of polyICLC emulsified in Montanide ISA-51 adjuvant will be administered on 1, 8, 15, 36, 57 and 78.
6MHP: 6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides
Montanide ISA-51: Montanide ISA-51 (Incomplete Freund's Adjuvant), local adjuvant
polyICLC: polyICLC, local adjuvant
|
Arm D:6MHP + polyICLC + Montanide ISA-51 + Cyclophosphamide
n=32 Participants
Parts 1 and 2: 200 mcg of 6MHP plus 1 mg of polyICLC emulsified in Montanide ISA-51 adjuvant will be administered on 1, 8, 15, 36, 57 and 78. Cyclophosphamide (50 mg) will be taken orally once a day for 7 days followed by a 7 day rest period. This will be repeated for 5 cycles. Cycles will begin on the following days:
* Day -6 (Cycle 1)
* Day 8 (Cycle 2)
* Day 22 (Cycle 3)
* Day 36 (Cycle 4)
* Day 50 (Cycle 5)
6MHP: 6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides
Montanide ISA-51: Montanide ISA-51 (Incomplete Freund's Adjuvant), local adjuvant
polyICLC: polyICLC, local adjuvant
Cyclophosphamide: Cyclophosphamide, systemic adjuvant
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
48 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
48 years
n=5 Participants
|
61 years
n=7 Participants
|
51 years
n=5 Participants
|
59 years
n=4 Participants
|
58 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
47 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
48 Participants
n=21 Participants
|
|
AJCC stage (v7)
AJCC (v7) Stage IIA
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
AJCC stage (v7)
AJCC (v7) Stage IIB/IIC
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
AJCC stage (v7)
AJCC (v7) Stage III
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
|
AJCC stage (v7)
AJCC (v7) Stage IV
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 30 days after administration of the last dose of 6MHP or cyclophosphamidePopulation: All 48 participants , including 47 on part 1 and 1 on part 2.
Treatment-related adverse events, by CTCAE v4, Dose-limiting toxicities.
Outcome measures
| Measure |
Arm A:6MHP + Montanide ISA-51
n=3 Participants
Part 1: 200 mcg of 6MHP emulsified in Montanide ISA-51 adjuvant will be administered on 1, 8, 15, 36, 57 and 78.
6MHP: 6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides
Montanide ISA-51: Montanide ISA-51 (Incomplete Freund's Adjuvant), local adjuvant
|
Arm B:6MHP + Montanide ISA-51 + Cyclophosphamide
n=7 Participants
Part 1: 200 mcg of 6MHP emulsified in Montanide ISA-51 adjuvant will be administered on 1, 8, 15, 36, 57 and 78. Cyclophosphamide (50 mg) will be taken orally once a day for 7 days followed by a 7 day rest period. This will be repeated for 5 cycles. Cycles will begin on the following days:
* Day -6 (Cycle 1)
* Day 8 (Cycle 2)
* Day 22 (Cycle 3)
* Day 36 (Cycle 4)
* Day 50 (Cycle 5)
6MHP: 6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides
Montanide ISA-51: Montanide ISA-51 (Incomplete Freund's Adjuvant), local adjuvant
Cyclophosphamide: Cyclophosphamide, systemic adjuvant
|
Arm C:6MHP + polyICLC + Montanide ISA-51
n=6 Participants
Part 1: 200 mcg of 6MHP plus 1 mg of polyICLC emulsified in Montanide ISA-51 adjuvant will be administered on 1, 8, 15, 36, 57 and 78.
6MHP: 6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides
Montanide ISA-51: Montanide ISA-51 (Incomplete Freund's Adjuvant), local adjuvant
polyICLC: polyICLC, local adjuvant
|
Arm D:6MHP + polyICLC + Montanide ISA-51 + Cyclophosphamide
n=32 Participants
Parts 1 and 2: 200 mcg of 6MHP plus 1 mg of polyICLC emulsified in Montanide ISA-51 adjuvant will be administered on 1, 8, 15, 36, 57 and 78. Cyclophosphamide (50 mg) will be taken orally once a day for 7 days followed by a 7 day rest period. This will be repeated for 5 cycles. Cycles will begin on the following days:
* Day -6 (Cycle 1)
* Day 8 (Cycle 2)
* Day 22 (Cycle 3)
* Day 36 (Cycle 4)
* Day 50 (Cycle 5)
6MHP: 6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides
Montanide ISA-51: Montanide ISA-51 (Incomplete Freund's Adjuvant), local adjuvant
polyICLC: polyICLC, local adjuvant
Cyclophosphamide: Cyclophosphamide, systemic adjuvant
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events
|
0 participants
|
1 participants
|
0 participants
|
2 participants
|
PRIMARY outcome
Timeframe: through day 85Population: All ennrolled and treated patients on Parts 1 and 2 of the study.
CD4+ T cell responses to 6 MHP: durable helper T cell response to 6MHP at 2 or more consecutive timepoints in the PBMC.
Outcome measures
| Measure |
Arm A:6MHP + Montanide ISA-51
n=3 Participants
Part 1: 200 mcg of 6MHP emulsified in Montanide ISA-51 adjuvant will be administered on 1, 8, 15, 36, 57 and 78.
6MHP: 6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides
Montanide ISA-51: Montanide ISA-51 (Incomplete Freund's Adjuvant), local adjuvant
|
Arm B:6MHP + Montanide ISA-51 + Cyclophosphamide
n=7 Participants
Part 1: 200 mcg of 6MHP emulsified in Montanide ISA-51 adjuvant will be administered on 1, 8, 15, 36, 57 and 78. Cyclophosphamide (50 mg) will be taken orally once a day for 7 days followed by a 7 day rest period. This will be repeated for 5 cycles. Cycles will begin on the following days:
* Day -6 (Cycle 1)
* Day 8 (Cycle 2)
* Day 22 (Cycle 3)
* Day 36 (Cycle 4)
* Day 50 (Cycle 5)
6MHP: 6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides
Montanide ISA-51: Montanide ISA-51 (Incomplete Freund's Adjuvant), local adjuvant
Cyclophosphamide: Cyclophosphamide, systemic adjuvant
|
Arm C:6MHP + polyICLC + Montanide ISA-51
n=6 Participants
Part 1: 200 mcg of 6MHP plus 1 mg of polyICLC emulsified in Montanide ISA-51 adjuvant will be administered on 1, 8, 15, 36, 57 and 78.
6MHP: 6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides
Montanide ISA-51: Montanide ISA-51 (Incomplete Freund's Adjuvant), local adjuvant
polyICLC: polyICLC, local adjuvant
|
Arm D:6MHP + polyICLC + Montanide ISA-51 + Cyclophosphamide
n=32 Participants
Parts 1 and 2: 200 mcg of 6MHP plus 1 mg of polyICLC emulsified in Montanide ISA-51 adjuvant will be administered on 1, 8, 15, 36, 57 and 78. Cyclophosphamide (50 mg) will be taken orally once a day for 7 days followed by a 7 day rest period. This will be repeated for 5 cycles. Cycles will begin on the following days:
* Day -6 (Cycle 1)
* Day 8 (Cycle 2)
* Day 22 (Cycle 3)
* Day 36 (Cycle 4)
* Day 50 (Cycle 5)
6MHP: 6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides
Montanide ISA-51: Montanide ISA-51 (Incomplete Freund's Adjuvant), local adjuvant
polyICLC: polyICLC, local adjuvant
Cyclophosphamide: Cyclophosphamide, systemic adjuvant
|
|---|---|---|---|---|
|
Immunogenicity-CD4+ T Cell Responses
|
0 Participants
|
2 Participants
|
4 Participants
|
15 Participants
|
PRIMARY outcome
Timeframe: through day 22Population: One patient enrolled on Part 2, was on Arm D.
increased infiltration of CD4+ and CD8+ T lymphocytes into melanoma metastases
Outcome measures
| Measure |
Arm A:6MHP + Montanide ISA-51
Part 1: 200 mcg of 6MHP emulsified in Montanide ISA-51 adjuvant will be administered on 1, 8, 15, 36, 57 and 78.
6MHP: 6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides
Montanide ISA-51: Montanide ISA-51 (Incomplete Freund's Adjuvant), local adjuvant
|
Arm B:6MHP + Montanide ISA-51 + Cyclophosphamide
Part 1: 200 mcg of 6MHP emulsified in Montanide ISA-51 adjuvant will be administered on 1, 8, 15, 36, 57 and 78. Cyclophosphamide (50 mg) will be taken orally once a day for 7 days followed by a 7 day rest period. This will be repeated for 5 cycles. Cycles will begin on the following days:
* Day -6 (Cycle 1)
* Day 8 (Cycle 2)
* Day 22 (Cycle 3)
* Day 36 (Cycle 4)
* Day 50 (Cycle 5)
6MHP: 6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides
Montanide ISA-51: Montanide ISA-51 (Incomplete Freund's Adjuvant), local adjuvant
Cyclophosphamide: Cyclophosphamide, systemic adjuvant
|
Arm C:6MHP + polyICLC + Montanide ISA-51
Part 1: 200 mcg of 6MHP plus 1 mg of polyICLC emulsified in Montanide ISA-51 adjuvant will be administered on 1, 8, 15, 36, 57 and 78.
6MHP: 6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides
Montanide ISA-51: Montanide ISA-51 (Incomplete Freund's Adjuvant), local adjuvant
polyICLC: polyICLC, local adjuvant
|
Arm D:6MHP + polyICLC + Montanide ISA-51 + Cyclophosphamide
n=1 Participants
Parts 1 and 2: 200 mcg of 6MHP plus 1 mg of polyICLC emulsified in Montanide ISA-51 adjuvant will be administered on 1, 8, 15, 36, 57 and 78. Cyclophosphamide (50 mg) will be taken orally once a day for 7 days followed by a 7 day rest period. This will be repeated for 5 cycles. Cycles will begin on the following days:
* Day -6 (Cycle 1)
* Day 8 (Cycle 2)
* Day 22 (Cycle 3)
* Day 36 (Cycle 4)
* Day 50 (Cycle 5)
6MHP: 6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides
Montanide ISA-51: Montanide ISA-51 (Incomplete Freund's Adjuvant), local adjuvant
polyICLC: polyICLC, local adjuvant
Cyclophosphamide: Cyclophosphamide, systemic adjuvant
|
|---|---|---|---|---|
|
Immunogenicity-modification of the Tumor Microenvironment (Part 2 Only)
CD8 T cells per mm2 in tumor pre-vaccine (day 0)
|
—
|
—
|
—
|
401 cells per mm2 of tumor
|
|
Immunogenicity-modification of the Tumor Microenvironment (Part 2 Only)
CD8 T cells per mm2 in tumor day 22
|
—
|
—
|
—
|
293 cells per mm2 of tumor
|
|
Immunogenicity-modification of the Tumor Microenvironment (Part 2 Only)
CD4 T cells per mm2 of tumor prevaccine (day 0)
|
—
|
—
|
—
|
1202 cells per mm2 of tumor
|
|
Immunogenicity-modification of the Tumor Microenvironment (Part 2 Only)
CD4 T cells per mm2 tumor day 22
|
—
|
—
|
—
|
1102 cells per mm2 of tumor
|
SECONDARY outcome
Timeframe: through day 85Population: Data were not collected for this endpoint. Funding for this trial has ended.
CD8+ T cell responses to defined melanoma antigens
Outcome measures
Outcome data not reported
Adverse Events
Arm A:6MHP + Montanide ISA-51
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm B:6MHP + Montanide ISA-51 + Cyclophosphamide
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Arm C:6MHP + polyICLC + Montanide ISA-51
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Arm D:6MHP + polyICLC + Montanide ISA-51 + Cyclophosphamide
Serious events: 0 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A:6MHP + Montanide ISA-51
n=3 participants at risk
Part 1: 200 mcg of 6MHP emulsified in Montanide ISA-51 adjuvant will be administered on 1, 8, 15, 36, 57 and 78.
6MHP: 6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides
Montanide ISA-51: Montanide ISA-51 (Incomplete Freund's Adjuvant), local adjuvant
|
Arm B:6MHP + Montanide ISA-51 + Cyclophosphamide
n=7 participants at risk
Part 1: 200 mcg of 6MHP emulsified in Montanide ISA-51 adjuvant will be administered on 1, 8, 15, 36, 57 and 78. Cyclophosphamide (50 mg) will be taken orally once a day for 7 days followed by a 7 day rest period. This will be repeated for 5 cycles. Cycles will begin on the following days:
* Day -6 (Cycle 1)
* Day 8 (Cycle 2)
* Day 22 (Cycle 3)
* Day 36 (Cycle 4)
* Day 50 (Cycle 5)
6MHP: 6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides
Montanide ISA-51: Montanide ISA-51 (Incomplete Freund's Adjuvant), local adjuvant
Cyclophosphamide: Cyclophosphamide, systemic adjuvant
|
Arm C:6MHP + polyICLC + Montanide ISA-51
n=6 participants at risk
Part 1: 200 mcg of 6MHP plus 1 mg of polyICLC emulsified in Montanide ISA-51 adjuvant will be administered on 1, 8, 15, 36, 57 and 78.
6MHP: 6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides
Montanide ISA-51: Montanide ISA-51 (Incomplete Freund's Adjuvant), local adjuvant
polyICLC: polyICLC, local adjuvant
|
Arm D:6MHP + polyICLC + Montanide ISA-51 + Cyclophosphamide
n=32 participants at risk
Parts 1 and 2: 200 mcg of 6MHP plus 1 mg of polyICLC emulsified in Montanide ISA-51 adjuvant will be administered on 1, 8, 15, 36, 57 and 78. Cyclophosphamide (50 mg) will be taken orally once a day for 7 days followed by a 7 day rest period. This will be repeated for 5 cycles. Cycles will begin on the following days:
* Day -6 (Cycle 1)
* Day 8 (Cycle 2)
* Day 22 (Cycle 3)
* Day 36 (Cycle 4)
* Day 50 (Cycle 5)
6MHP: 6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides
Montanide ISA-51: Montanide ISA-51 (Incomplete Freund's Adjuvant), local adjuvant
polyICLC: polyICLC, local adjuvant
Cyclophosphamide: Cyclophosphamide, systemic adjuvant
|
|---|---|---|---|---|
|
Infections and infestations
sepsis
|
0.00%
0/3 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
|
14.3%
1/7 • Number of events 1 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
|
0.00%
0/6 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
|
0.00%
0/32 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
|
Other adverse events
| Measure |
Arm A:6MHP + Montanide ISA-51
n=3 participants at risk
Part 1: 200 mcg of 6MHP emulsified in Montanide ISA-51 adjuvant will be administered on 1, 8, 15, 36, 57 and 78.
6MHP: 6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides
Montanide ISA-51: Montanide ISA-51 (Incomplete Freund's Adjuvant), local adjuvant
|
Arm B:6MHP + Montanide ISA-51 + Cyclophosphamide
n=7 participants at risk
Part 1: 200 mcg of 6MHP emulsified in Montanide ISA-51 adjuvant will be administered on 1, 8, 15, 36, 57 and 78. Cyclophosphamide (50 mg) will be taken orally once a day for 7 days followed by a 7 day rest period. This will be repeated for 5 cycles. Cycles will begin on the following days:
* Day -6 (Cycle 1)
* Day 8 (Cycle 2)
* Day 22 (Cycle 3)
* Day 36 (Cycle 4)
* Day 50 (Cycle 5)
6MHP: 6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides
Montanide ISA-51: Montanide ISA-51 (Incomplete Freund's Adjuvant), local adjuvant
Cyclophosphamide: Cyclophosphamide, systemic adjuvant
|
Arm C:6MHP + polyICLC + Montanide ISA-51
n=6 participants at risk
Part 1: 200 mcg of 6MHP plus 1 mg of polyICLC emulsified in Montanide ISA-51 adjuvant will be administered on 1, 8, 15, 36, 57 and 78.
6MHP: 6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides
Montanide ISA-51: Montanide ISA-51 (Incomplete Freund's Adjuvant), local adjuvant
polyICLC: polyICLC, local adjuvant
|
Arm D:6MHP + polyICLC + Montanide ISA-51 + Cyclophosphamide
n=32 participants at risk
Parts 1 and 2: 200 mcg of 6MHP plus 1 mg of polyICLC emulsified in Montanide ISA-51 adjuvant will be administered on 1, 8, 15, 36, 57 and 78. Cyclophosphamide (50 mg) will be taken orally once a day for 7 days followed by a 7 day rest period. This will be repeated for 5 cycles. Cycles will begin on the following days:
* Day -6 (Cycle 1)
* Day 8 (Cycle 2)
* Day 22 (Cycle 3)
* Day 36 (Cycle 4)
* Day 50 (Cycle 5)
6MHP: 6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides
Montanide ISA-51: Montanide ISA-51 (Incomplete Freund's Adjuvant), local adjuvant
polyICLC: polyICLC, local adjuvant
Cyclophosphamide: Cyclophosphamide, systemic adjuvant
|
|---|---|---|---|---|
|
General disorders
Injection site reaction
|
100.0%
3/3 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
|
100.0%
7/7 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
|
100.0%
6/6 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
|
100.0%
32/32 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
100.0%
3/3 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
|
100.0%
7/7 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
|
100.0%
6/6 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
|
100.0%
32/32 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
|
|
General disorders
Fatigue
|
66.7%
2/3 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
|
42.9%
3/7 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
|
66.7%
4/6 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
|
62.5%
20/32 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
|
28.6%
2/7 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
|
66.7%
4/6 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
|
25.0%
8/32 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
66.7%
2/3 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
|
0.00%
0/7 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
|
33.3%
2/6 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
|
18.8%
6/32 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
|
28.6%
2/7 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
|
50.0%
3/6 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
|
15.6%
5/32 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
|
|
General disorders
Chills
|
0.00%
0/3 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
|
0.00%
0/7 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
|
33.3%
2/6 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
|
21.9%
7/32 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
|
|
General disorders
Flu-like symptoms
|
0.00%
0/3 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
|
14.3%
1/7 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
|
16.7%
1/6 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
|
21.9%
7/32 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
66.7%
2/3 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
|
28.6%
2/7 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
|
0.00%
0/6 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
|
15.6%
5/32 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/3 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
|
0.00%
0/7 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
|
16.7%
1/6 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
|
25.0%
8/32 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
|
|
General disorders
fever
|
0.00%
0/3 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
|
28.6%
2/7 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
|
0.00%
0/6 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
|
15.6%
5/32 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
|
0.00%
0/7 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
|
0.00%
0/6 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
|
15.6%
5/32 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
|
14.3%
1/7 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
|
0.00%
0/6 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
|
12.5%
4/32 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
|
|
Gastrointestinal disorders
Mucositis, oral
|
0.00%
0/3 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
|
28.6%
2/7 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
|
0.00%
0/6 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
|
6.2%
2/32 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/3 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
|
14.3%
1/7 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
|
0.00%
0/6 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
|
9.4%
3/32 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
|
14.3%
1/7 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
|
16.7%
1/6 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
|
3.1%
1/32 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
|
0.00%
0/7 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
|
0.00%
0/6 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
|
9.4%
3/32 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/3 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
|
0.00%
0/7 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
|
0.00%
0/6 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
|
9.4%
3/32 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
|
|
Vascular disorders
Flushing
|
33.3%
1/3 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
|
14.3%
1/7 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
|
16.7%
1/6 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
|
0.00%
0/32 • Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
The study will be monitored continuously for treatment-related adverse events. A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria: * ≥ Grade 3 * ≥ Grade 1 ocular adverse events as defined below * ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
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Additional Information
Craig Slingluff, MD, Professor of Surgery
University of Virginia
Phone: 434-924-9311
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place