Trial Outcomes & Findings for Talimogene Laherparepvec and Pembrolizumab in Treating Patients With Stage III-IV Melanoma (NCT NCT02965716)
NCT ID: NCT02965716
Last Updated: 2025-11-18
Results Overview
Number of participants with a complete response, defined as the disappearance of all target and non-target lesions, or partial response, defined as a greater than or equal to 30% decrease under baseline of the sum of appropriate diameters of all target measurable legions. ORR is measured using RECIST 1.1 guidelines.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
43 participants
Primary outcome timeframe
Up to 5 years post registration or until death
Results posted on
2025-11-18
Participant Flow
43 participants were enrolled to the study, 4 participants were determined to be ineligible, and 1 was not analyzable.
Participant milestones
| Measure |
Cohort A (Visceral): T-VEC + MK-3475 (Pembrolizumab)
Cohort A (Visceral): Patients will take up to 4 ml of 1 million PFU/mL T-VEC intralesionally on cycle 1, and up to 4 ml of 100 million PFU/mL T-VEC intralesionally on cycles 2-36, as well as 200 mg of Pembrolizumab taken by IV over 30 minutes on cycles 1-36.
|
Cohort B (Non-Visceral): T-VEC + MK-3475 (Pembrolizumab)
Cohort B (Non-Visceral): Patients will take up to 4 ml of 1 million PFU/mL T-VEC intralesionally on cycle 1, and up to 4 ml of 100 million PFU/mL T-VEC intralesionally on cycles 2-36, as well as 200 mg of Pembrolizumab taken by IV over 30 minutes on cycles 1-36.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
27
|
|
Overall Study
COMPLETED
|
0
|
3
|
|
Overall Study
NOT COMPLETED
|
11
|
24
|
Reasons for withdrawal
| Measure |
Cohort A (Visceral): T-VEC + MK-3475 (Pembrolizumab)
Cohort A (Visceral): Patients will take up to 4 ml of 1 million PFU/mL T-VEC intralesionally on cycle 1, and up to 4 ml of 100 million PFU/mL T-VEC intralesionally on cycles 2-36, as well as 200 mg of Pembrolizumab taken by IV over 30 minutes on cycles 1-36.
|
Cohort B (Non-Visceral): T-VEC + MK-3475 (Pembrolizumab)
Cohort B (Non-Visceral): Patients will take up to 4 ml of 1 million PFU/mL T-VEC intralesionally on cycle 1, and up to 4 ml of 100 million PFU/mL T-VEC intralesionally on cycles 2-36, as well as 200 mg of Pembrolizumab taken by IV over 30 minutes on cycles 1-36.
|
|---|---|---|
|
Overall Study
Refusal Unrelated to Adverse Event
|
1
|
5
|
|
Overall Study
Progression/Relapse
|
8
|
16
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Not Protocol Specified
|
1
|
3
|
Baseline Characteristics
Talimogene Laherparepvec and Pembrolizumab in Treating Patients With Stage III-IV Melanoma
Baseline characteristics by cohort
| Measure |
Cohort A (Visceral): T-VEC + MK-3475 (Pembrolizumab)
n=11 Participants
Cohort A (Visceral): Patients will take up to 4 ml of 1 million PFU/mL T-VEC intralesionally on cycle 1, and up to 4 ml of 100 million PFU/mL T-VEC intralesionally on cycles 2-36, as well as 200 mg of Pembrolizumab taken by IV over 30 minutes on cycles 1-36.
|
Cohort B (Non-Visceral): T-VEC + MK-3475 (Pembrolizumab)
n=27 Participants
Cohort B (Non-Visceral): Patients will take up to 4 ml of 1 million PFU/mL T-VEC intralesionally on cycle 1, and up to 4 ml of 100 million PFU/mL T-VEC intralesionally on cycles 2-36, as well as 200 mg of Pembrolizumab taken by IV over 30 minutes on cycles 1-36.
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.8 years
n=202 Participants
|
61.3 years
n=283 Participants
|
61.55 years
n=120 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=202 Participants
|
11 Participants
n=283 Participants
|
18 Participants
n=120 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=202 Participants
|
16 Participants
n=283 Participants
|
20 Participants
n=120 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=202 Participants
|
2 Participants
n=283 Participants
|
3 Participants
n=120 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=202 Participants
|
24 Participants
n=283 Participants
|
32 Participants
n=120 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=202 Participants
|
1 Participants
n=283 Participants
|
3 Participants
n=120 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=202 Participants
|
1 Participants
n=283 Participants
|
1 Participants
n=120 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=202 Participants
|
1 Participants
n=283 Participants
|
1 Participants
n=120 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=202 Participants
|
23 Participants
n=283 Participants
|
31 Participants
n=120 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
1 Participants
n=120 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=202 Participants
|
2 Participants
n=283 Participants
|
4 Participants
n=120 Participants
|
|
Performance Status
0
|
3 Participants
n=202 Participants
|
14 Participants
n=283 Participants
|
17 Participants
n=120 Participants
|
|
Performance Status
1
|
7 Participants
n=202 Participants
|
11 Participants
n=283 Participants
|
18 Participants
n=120 Participants
|
|
Performance Status
2
|
1 Participants
n=202 Participants
|
2 Participants
n=283 Participants
|
3 Participants
n=120 Participants
|
|
Resistance To Prior Checkpoint Inhibitor
Acquired
|
3 Participants
n=202 Participants
|
3 Participants
n=283 Participants
|
6 Participants
n=120 Participants
|
|
Resistance To Prior Checkpoint Inhibitor
Primary
|
8 Participants
n=202 Participants
|
24 Participants
n=283 Participants
|
32 Participants
n=120 Participants
|
PRIMARY outcome
Timeframe: Up to 5 years post registration or until deathPopulation: Participants who are eligible and analyzable.
Number of participants with a complete response, defined as the disappearance of all target and non-target lesions, or partial response, defined as a greater than or equal to 30% decrease under baseline of the sum of appropriate diameters of all target measurable legions. ORR is measured using RECIST 1.1 guidelines.
Outcome measures
| Measure |
Cohort A (Visceral): T-VEC + MK-3475 (Pembrolizumab)
n=11 Participants
Cohort A (Visceral): Patients will take up to 4 ml of 1 million PFU/mL T-VEC intralesionally on cycle 1, and up to 4 ml of 100 million PFU/mL T-VEC intralesionally on cycles 2-36, as well as 200 mg of Pembrolizumab taken by IV over 30 minutes on cycles 1-36.
|
Cohort B (Non-Visceral): T-VEC + MK-3475 (Pembrolizumab)
n=27 Participants
Cohort B (Non-Visceral): Patients will take up to 4 ml of 1 million PFU/mL T-VEC intralesionally on cycle 1, and up to 4 ml of 100 million PFU/mL T-VEC intralesionally on cycles 2-36, as well as 200 mg of Pembrolizumab taken by IV over 30 minutes on cycles 1-36.
|
|---|---|---|
|
Objective Response Rate (ORR)
Complete Response
|
0 Participants
|
2 Participants
|
|
Objective Response Rate (ORR)
Partial Response
|
0 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Up to 5 years post registration or until deathPopulation: Participants who are eligible and analyzable.
Number of participants with complete or partial response per RECIST 1.1 with no evidence of disease progression for at least 180 days from the initial documentation of CR/PR.
Outcome measures
| Measure |
Cohort A (Visceral): T-VEC + MK-3475 (Pembrolizumab)
n=11 Participants
Cohort A (Visceral): Patients will take up to 4 ml of 1 million PFU/mL T-VEC intralesionally on cycle 1, and up to 4 ml of 100 million PFU/mL T-VEC intralesionally on cycles 2-36, as well as 200 mg of Pembrolizumab taken by IV over 30 minutes on cycles 1-36.
|
Cohort B (Non-Visceral): T-VEC + MK-3475 (Pembrolizumab)
n=27 Participants
Cohort B (Non-Visceral): Patients will take up to 4 ml of 1 million PFU/mL T-VEC intralesionally on cycle 1, and up to 4 ml of 100 million PFU/mL T-VEC intralesionally on cycles 2-36, as well as 200 mg of Pembrolizumab taken by IV over 30 minutes on cycles 1-36.
|
|---|---|---|
|
Durable Response Rate
|
0 participants
Interval 0.0 to 28.0
|
4 participants
Interval 4.0 to 34.0
|
SECONDARY outcome
Timeframe: Up to 5 years post registration or until deathPopulation: Participants who are eligible and analyzable and had lesions deemed injectable at any time prior to progression.
Number of participants with confirmed and unconfirmed complete and partial responses in injected lesions. A confirmed complete response (CR) is defined as 2 or more consecutive objective statuses of CR a minimum of 4 weeks apart, a confirmed partial response is defined as 2 or more consecutive objective statuses of PR or better a minimum of 4 weeks apart but no qualifying as a CR. A unconfirmed CR is defined as 1 objective status of CR but not qualifying as a CR or PR, a unconfirmed PR is defined as 1 objective status of PR but not qualifying as CR, PR, or unconfirmed CR. ORR is measured per RECIST 1.1 guidelines.
Outcome measures
| Measure |
Cohort A (Visceral): T-VEC + MK-3475 (Pembrolizumab)
n=11 Participants
Cohort A (Visceral): Patients will take up to 4 ml of 1 million PFU/mL T-VEC intralesionally on cycle 1, and up to 4 ml of 100 million PFU/mL T-VEC intralesionally on cycles 2-36, as well as 200 mg of Pembrolizumab taken by IV over 30 minutes on cycles 1-36.
|
Cohort B (Non-Visceral): T-VEC + MK-3475 (Pembrolizumab)
n=27 Participants
Cohort B (Non-Visceral): Patients will take up to 4 ml of 1 million PFU/mL T-VEC intralesionally on cycle 1, and up to 4 ml of 100 million PFU/mL T-VEC intralesionally on cycles 2-36, as well as 200 mg of Pembrolizumab taken by IV over 30 minutes on cycles 1-36.
|
|---|---|---|
|
Objective Response Rate (ORR) in Injected Lesions
Complete Response
|
0 Participants
|
2 Participants
|
|
Objective Response Rate (ORR) in Injected Lesions
Partial Response
|
0 Participants
|
4 Participants
|
|
Objective Response Rate (ORR) in Injected Lesions
Unconfirmed Complete Response
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 5 years post registration or until deathPopulation: Eligible participants who had lesions that were not injected at Cycle 1, Week 1.
Number of participants with confirmed and unconfirmed complete and partial responses in non-visceral, non-injected lesions. A confirmed complete response (CR) is defined as 2 or more consecutive objective statuses of CR a minimum of 4 weeks apart, a confirmed partial response is defined as 2 or more consecutive objective statuses of PR or better a minimum of 4 weeks apart but no qualifying as a CR. A unconfirmed CR is defined as 1 objective status of CR but not qualifying as a CR or PR, a unconfirmed PR is defined as 1 objective status of PR but not qualifying as CR, PR, or unconfirmed CR. ORR is measured per RECIST 1.1 guidelines.
Outcome measures
| Measure |
Cohort A (Visceral): T-VEC + MK-3475 (Pembrolizumab)
n=8 Participants
Cohort A (Visceral): Patients will take up to 4 ml of 1 million PFU/mL T-VEC intralesionally on cycle 1, and up to 4 ml of 100 million PFU/mL T-VEC intralesionally on cycles 2-36, as well as 200 mg of Pembrolizumab taken by IV over 30 minutes on cycles 1-36.
|
Cohort B (Non-Visceral): T-VEC + MK-3475 (Pembrolizumab)
n=19 Participants
Cohort B (Non-Visceral): Patients will take up to 4 ml of 1 million PFU/mL T-VEC intralesionally on cycle 1, and up to 4 ml of 100 million PFU/mL T-VEC intralesionally on cycles 2-36, as well as 200 mg of Pembrolizumab taken by IV over 30 minutes on cycles 1-36.
|
|---|---|---|
|
Objective Response Rate (ORR) in Non-Visceral, Non-Injected Lesions
Complete Response
|
0 Participants
|
2 Participants
|
|
Objective Response Rate (ORR) in Non-Visceral, Non-Injected Lesions
Partial Response
|
0 Participants
|
1 Participants
|
|
Objective Response Rate (ORR) in Non-Visceral, Non-Injected Lesions
Unconfirmed Complete Response
|
0 Participants
|
1 Participants
|
|
Objective Response Rate (ORR) in Non-Visceral, Non-Injected Lesions
Unconfirmed Partial Response
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 5 years post registration or until deathPopulation: Participants who are eligible and analyzable and had visceral lesions present at baseline.
Number of participants with confirmed and unconfirmed complete and partial responses in visceral lesions. A confirmed complete response (CR) is defined as 2 or more consecutive objective statuses of CR a minimum of 4 weeks apart, a confirmed partial response is defined as 2 or more consecutive objective statuses of PR or better a minimum of 4 weeks apart but no qualifying as a CR. A unconfirmed CR is defined as 1 objective status of CR but not qualifying as a CR or PR, a unconfirmed PR is defined as 1 objective status of PR but not qualifying as CR, PR, or unconfirmed CR. ORR is measured per RECIST 1.1 guidelines.
Outcome measures
| Measure |
Cohort A (Visceral): T-VEC + MK-3475 (Pembrolizumab)
n=11 Participants
Cohort A (Visceral): Patients will take up to 4 ml of 1 million PFU/mL T-VEC intralesionally on cycle 1, and up to 4 ml of 100 million PFU/mL T-VEC intralesionally on cycles 2-36, as well as 200 mg of Pembrolizumab taken by IV over 30 minutes on cycles 1-36.
|
Cohort B (Non-Visceral): T-VEC + MK-3475 (Pembrolizumab)
Cohort B (Non-Visceral): Patients will take up to 4 ml of 1 million PFU/mL T-VEC intralesionally on cycle 1, and up to 4 ml of 100 million PFU/mL T-VEC intralesionally on cycles 2-36, as well as 200 mg of Pembrolizumab taken by IV over 30 minutes on cycles 1-36.
|
|---|---|---|
|
Objective Response Rate (ORR) in Visceral Lesions (Cohort A)
Confirmed Complete Response
|
0 Participants
|
—
|
|
Objective Response Rate (ORR) in Visceral Lesions (Cohort A)
Confirmed Partial Response
|
0 Participants
|
—
|
|
Objective Response Rate (ORR) in Visceral Lesions (Cohort A)
Unconfirmed Complete Response
|
0 Participants
|
—
|
|
Objective Response Rate (ORR) in Visceral Lesions (Cohort A)
Unconfirmed Partial Response
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 5 years post registration or until deathPopulation: Participants who are eligible and analyzable
Time from date of first registration to date of first documentation of progression or death due to any cause. Patients last known to be alive without report of progression are censored at date of last contact. For a patient to have "progressed", one or more of the following must occur: 20% increase in the sum of appropriate diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline, as well as an absolute increase of at least 0.5 cm. Unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided). Appearance of any new lesion/site. Death due to disease without prior documentation of progression and without symptomatic deterioration.
Outcome measures
| Measure |
Cohort A (Visceral): T-VEC + MK-3475 (Pembrolizumab)
n=11 Participants
Cohort A (Visceral): Patients will take up to 4 ml of 1 million PFU/mL T-VEC intralesionally on cycle 1, and up to 4 ml of 100 million PFU/mL T-VEC intralesionally on cycles 2-36, as well as 200 mg of Pembrolizumab taken by IV over 30 minutes on cycles 1-36.
|
Cohort B (Non-Visceral): T-VEC + MK-3475 (Pembrolizumab)
n=27 Participants
Cohort B (Non-Visceral): Patients will take up to 4 ml of 1 million PFU/mL T-VEC intralesionally on cycle 1, and up to 4 ml of 100 million PFU/mL T-VEC intralesionally on cycles 2-36, as well as 200 mg of Pembrolizumab taken by IV over 30 minutes on cycles 1-36.
|
|---|---|---|
|
Progression-Free Survival (PFS)
|
2.1 months
Interval 0.7 to 5.5
|
2.3 months
Interval 1.9 to 6.2
|
SECONDARY outcome
Timeframe: Up to 5 years post registration or until deathPopulation: Participants who are eligible and analyzable
Time from date of registration to date of death due to any cause. Participants last known to be alive are censored at date of last contact.
Outcome measures
| Measure |
Cohort A (Visceral): T-VEC + MK-3475 (Pembrolizumab)
n=11 Participants
Cohort A (Visceral): Patients will take up to 4 ml of 1 million PFU/mL T-VEC intralesionally on cycle 1, and up to 4 ml of 100 million PFU/mL T-VEC intralesionally on cycles 2-36, as well as 200 mg of Pembrolizumab taken by IV over 30 minutes on cycles 1-36.
|
Cohort B (Non-Visceral): T-VEC + MK-3475 (Pembrolizumab)
n=27 Participants
Cohort B (Non-Visceral): Patients will take up to 4 ml of 1 million PFU/mL T-VEC intralesionally on cycle 1, and up to 4 ml of 100 million PFU/mL T-VEC intralesionally on cycles 2-36, as well as 200 mg of Pembrolizumab taken by IV over 30 minutes on cycles 1-36.
|
|---|---|---|
|
Overall Survival (OS)
|
5.2 months
Interval 1.0 to
Some patients are still alive at the time of reporting so upper confidence boundary is not reportable.
|
NA months
Interval 19.1 to
\>50% of patients are still alive at the time of reporting so certain data is not reportable.
|
SECONDARY outcome
Timeframe: Duration of treatment and 5 years follow-up or death, whichever occurs first.Population: Participants who were eligible and received at least one dose of protocol treatment.
Only adverse events that are possibly, probably or definitely related to study drug are reported. CTCAE Version 4.0 was used for AE reporting.
Outcome measures
| Measure |
Cohort A (Visceral): T-VEC + MK-3475 (Pembrolizumab)
n=11 Participants
Cohort A (Visceral): Patients will take up to 4 ml of 1 million PFU/mL T-VEC intralesionally on cycle 1, and up to 4 ml of 100 million PFU/mL T-VEC intralesionally on cycles 2-36, as well as 200 mg of Pembrolizumab taken by IV over 30 minutes on cycles 1-36.
|
Cohort B (Non-Visceral): T-VEC + MK-3475 (Pembrolizumab)
n=27 Participants
Cohort B (Non-Visceral): Patients will take up to 4 ml of 1 million PFU/mL T-VEC intralesionally on cycle 1, and up to 4 ml of 100 million PFU/mL T-VEC intralesionally on cycles 2-36, as well as 200 mg of Pembrolizumab taken by IV over 30 minutes on cycles 1-36.
|
|---|---|---|
|
Number of Participants With Gr 1 Through 5 Adverse Events That Are Related to Study Drugs
Fatigue
|
0 Participants
|
2 Participants
|
|
Number of Participants With Gr 1 Through 5 Adverse Events That Are Related to Study Drugs
Hyponatremia
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 1 Through 5 Adverse Events That Are Related to Study Drugs
Hypoxia
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 1 Through 5 Adverse Events That Are Related to Study Drugs
Injection site reaction
|
0 Participants
|
2 Participants
|
|
Number of Participants With Gr 1 Through 5 Adverse Events That Are Related to Study Drugs
Lymphocyte count decreased
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 1 Through 5 Adverse Events That Are Related to Study Drugs
Tumor pain
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 1 Through 5 Adverse Events That Are Related to Study Drugs
Dyspnea
|
0 Participants
|
1 Participants
|
Adverse Events
Cohort A (Visceral): T-VEC + MK-3475 (Pembrolizumab)
Serious events: 6 serious events
Other events: 10 other events
Deaths: 1 deaths
Cohort B (Non-Visceral): T-VEC + MK-3475 (Pembrolizumab)
Serious events: 3 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort A (Visceral): T-VEC + MK-3475 (Pembrolizumab)
n=11 participants at risk
Cohort A (Visceral): Patients will take up to 4 ml of 1 million PFU/mL T-VEC intralesionally on cycle 1, and up to 4 ml of 100 million PFU/mL T-VEC intralesionally on cycles 2-36, as well as 200 mg of Pembrolizumab taken by IV over 30 minutes on cycles 1-36.
|
Cohort B (Non-Visceral): T-VEC + MK-3475 (Pembrolizumab)
n=27 participants at risk
Cohort B (Non-Visceral): Patients will take up to 4 ml of 1 million PFU/mL T-VEC intralesionally on cycle 1, and up to 4 ml of 100 million PFU/mL T-VEC intralesionally on cycles 2-36, as well as 200 mg of Pembrolizumab taken by IV over 30 minutes on cycles 1-36.
|
|---|---|---|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
3.7%
1/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Cardiac disorders
Sinus tachycardia
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
3.7%
1/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Eye disorders
Blurred vision
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
0.00%
0/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Gastrointestinal disorders
Abdominal pain
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
0.00%
0/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
3.7%
1/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Gastrointestinal disorders
Nausea
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
0.00%
0/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
0.00%
0/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Gastrointestinal disorders
Vomiting
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
0.00%
0/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
General disorders
Death NOS
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
0.00%
0/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
General disorders
Fatigue
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
3.7%
1/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
General disorders
Fever
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
3.7%
1/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Infections and infestations
Lung infection
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
0.00%
0/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Infections and infestations
Skin infection
|
0.00%
0/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
3.7%
1/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Investigations
Lymphocyte count decreased
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
0.00%
0/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Investigations
Weight loss
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
0.00%
0/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Metabolism and nutrition disorders
Anorexia
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
0.00%
0/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
3.7%
1/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
18.2%
2/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
0.00%
0/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified - Other
|
18.2%
2/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
3.7%
1/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
3.7%
1/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
3.7%
1/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
3.7%
1/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Vascular disorders
Hypotension
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
0.00%
0/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Vascular disorders
Thromboembolic event
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
0.00%
0/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
Other adverse events
| Measure |
Cohort A (Visceral): T-VEC + MK-3475 (Pembrolizumab)
n=11 participants at risk
Cohort A (Visceral): Patients will take up to 4 ml of 1 million PFU/mL T-VEC intralesionally on cycle 1, and up to 4 ml of 100 million PFU/mL T-VEC intralesionally on cycles 2-36, as well as 200 mg of Pembrolizumab taken by IV over 30 minutes on cycles 1-36.
|
Cohort B (Non-Visceral): T-VEC + MK-3475 (Pembrolizumab)
n=27 participants at risk
Cohort B (Non-Visceral): Patients will take up to 4 ml of 1 million PFU/mL T-VEC intralesionally on cycle 1, and up to 4 ml of 100 million PFU/mL T-VEC intralesionally on cycles 2-36, as well as 200 mg of Pembrolizumab taken by IV over 30 minutes on cycles 1-36.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
14.8%
4/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Endocrine disorders
Hypothyroidism
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
14.8%
4/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Eye disorders
Blurred vision
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
3.7%
1/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Eye disorders
Dry eye
|
0.00%
0/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
7.4%
2/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Eye disorders
Eye disorders-Other
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
0.00%
0/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Blood and lymphatic system disorders
Anemia
|
27.3%
3/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
29.6%
8/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
0.00%
0/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Cardiac disorders
Sinus tachycardia
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
0.00%
0/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Gastrointestinal disorders
Bloating
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
3.7%
1/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Gastrointestinal disorders
Constipation
|
18.2%
2/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
18.5%
5/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Gastrointestinal disorders
Diarrhea
|
18.2%
2/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
22.2%
6/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Gastrointestinal disorders
Dyspepsia
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
0.00%
0/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Gastrointestinal disorders
Mucositis oral
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
0.00%
0/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Gastrointestinal disorders
Nausea
|
45.5%
5/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
40.7%
11/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Gastrointestinal disorders
Proctitis
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
0.00%
0/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
7.4%
2/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Gastrointestinal disorders
Vomiting
|
27.3%
3/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
14.8%
4/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
General disorders
Chills
|
27.3%
3/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
25.9%
7/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
General disorders
Edema limbs
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
0.00%
0/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
General disorders
Fatigue
|
45.5%
5/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
48.1%
13/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
General disorders
Fever
|
18.2%
2/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
22.2%
6/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
General disorders
Flu like symptoms
|
0.00%
0/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
33.3%
9/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
General disorders
General disorders and admin site conditions - Other
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
3.7%
1/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
General disorders
Injection site reaction
|
0.00%
0/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
22.2%
6/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
General disorders
Malaise
|
0.00%
0/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
7.4%
2/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
7.4%
2/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
General disorders
Pain
|
0.00%
0/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
25.9%
7/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
0.00%
0/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Infections and infestations
Anorectal infection
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
0.00%
0/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Infections and infestations
Infections and infestations-Other
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
3.7%
1/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Injury, poisoning and procedural complications
Injury, poison and procedural complications - Other
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
3.7%
1/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
7.4%
2/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Investigations
Aspartate aminotransferase increased
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
7.4%
2/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Investigations
Blood bilirubin increased
|
18.2%
2/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
3.7%
1/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Investigations
Creatinine increased
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
11.1%
3/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Investigations
Lymphocyte count decreased
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
11.1%
3/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Investigations
Neutrophil count decreased
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
3.7%
1/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Investigations
Platelet count decreased
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
3.7%
1/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Investigations
Weight gain
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
0.00%
0/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Investigations
Weight loss
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
0.00%
0/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Investigations
White blood cell decreased
|
18.2%
2/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
3.7%
1/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Metabolism and nutrition disorders
Anorexia
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
14.8%
4/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
18.2%
2/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
33.3%
9/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
7.4%
2/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
18.2%
2/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
3.7%
1/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
11.1%
3/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
18.2%
2/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
14.8%
4/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
18.2%
2/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
3.7%
1/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
7.4%
2/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
11.1%
3/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
18.2%
2/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
7.4%
2/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased cervical spine
|
0.00%
0/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
7.4%
2/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
0.00%
0/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
14.8%
4/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
7.4%
2/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
18.5%
5/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified - Other
|
0.00%
0/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
7.4%
2/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
18.5%
5/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Nervous system disorders
Dizziness
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
7.4%
2/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Nervous system disorders
Headache
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
18.5%
5/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
0.00%
0/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Nervous system disorders
Presyncope
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
0.00%
0/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Psychiatric disorders
Anxiety
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
0.00%
0/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Psychiatric disorders
Confusion
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
3.7%
1/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Psychiatric disorders
Depression
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
3.7%
1/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Psychiatric disorders
Insomnia
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
7.4%
2/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Renal and urinary disorders
Urinary retention
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
0.00%
0/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
14.8%
4/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
27.3%
3/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
11.1%
3/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
7.4%
2/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
3.7%
1/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic and mediastinal disorders - Other
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
3.7%
1/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
0.00%
0/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
0.00%
0/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
7.4%
2/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
27.3%
3/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
11.1%
3/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
11.1%
3/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
7.4%
2/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
0.00%
0/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
14.8%
4/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
0.00%
0/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Surgical and medical procedures
Surgical and medical procedures-Other
|
0.00%
0/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
7.4%
2/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Vascular disorders
Hypertension
|
0.00%
0/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
11.1%
3/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
|
Vascular disorders
Hypotension
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
7.4%
2/27 • Duration of treatment and follow up until death or 5 years post registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for reporting toxicities. There were 11 participants in Cohort A and 27 participants in Cohort B that were evaluable for AEs.
|
Additional Information
Melanoma Committee Statistician
SWOG Data Management Center
Phone: 206-667-4623
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60