Trial Outcomes & Findings for RADVAX™: A STRATIFIED PHASE I/II DOSE ESCALATION TRIAL OF HYPOFRACTIONATED RADIOTHERAPY FOLLOWED BY IPILIMUMAB IN METASTATIC MELANOMA (NCT NCT01497808)
NCT ID: NCT01497808
Last Updated: 2021-08-10
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
22 participants
Primary outcome timeframe
30 days
Results posted on
2021-08-10
Participant Flow
Participant milestones
| Measure |
Ipilimumab and Radiotherapy (8 Gy x 2)
Ipilimumab
Stereotactic Body Radiation Therapy
|
Ipilimumab and Radiotherapy (8 Gy x 3)
|
Ipilimumab and Radiotherapy (6 Gy x 2)
|
Ipilimumab and Radiotherapy (6 Gy x 3)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
4
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
4
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
RADVAX™: A STRATIFIED PHASE I/II DOSE ESCALATION TRIAL OF HYPOFRACTIONATED RADIOTHERAPY FOLLOWED BY IPILIMUMAB IN METASTATIC MELANOMA
Baseline characteristics by cohort
| Measure |
Ipilimumab and Radiotherapy (8 Gy x 2)
n=6 Participants
Ipilimumab
Stereotactic Body Radiation Therapy
|
Ipilimumab and Radiotherapy (8 Gy x 3)
n=4 Participants
|
Ipilimumab and Radiotherapy (6 Gy x 2)
n=6 Participants
|
Ipilimumab and Radiotherapy (6 Gy x 3)
n=6 Participants
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
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, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
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
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
22 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
|
|
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
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
22 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
|
0 Participants
n=4 Participants
|
0 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
|
PRIMARY outcome
Timeframe: 30 daysOutcome measures
| Measure |
Ipilimumab and Radiotherapy (8 Gy x 2)
n=6 Participants
Ipilimumab
Stereotactic Body Radiation Therapy
|
Ipilimumab and Radiotherapy (8 Gy x 3)
n=4 Participants
|
Ipilimumab and Radiotherapy (6 Gy x 2)
n=6 Participants
|
Ipilimumab and Radiotherapy (6 Gy x 3)
n=6 Participants
|
|---|---|---|---|---|
|
Dose-limiting Toxicity (DLT)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: after 30 daysOutcome measures
| Measure |
Ipilimumab and Radiotherapy (8 Gy x 2)
n=6 Participants
Ipilimumab
Stereotactic Body Radiation Therapy
|
Ipilimumab and Radiotherapy (8 Gy x 3)
n=4 Participants
|
Ipilimumab and Radiotherapy (6 Gy x 2)
n=6 Participants
|
Ipilimumab and Radiotherapy (6 Gy x 3)
n=6 Participants
|
|---|---|---|---|---|
|
Participants With Adverse Events
|
6 Participants
|
4 Participants
|
6 Participants
|
6 Participants
|
Adverse Events
Ipilimumab and Radiotherapy (8 Gy x 2)
Serious events: 5 serious events
Other events: 5 other events
Deaths: 0 deaths
Ipilimumab and Radiotherapy (8 Gy x 3)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Ipilimumab and Radiotherapy (6 Gy x 2)
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Ipilimumab and Radiotherapy (6 Gy x 3)
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ipilimumab and Radiotherapy (8 Gy x 2)
n=6 participants at risk
|
Ipilimumab and Radiotherapy (8 Gy x 3)
n=4 participants at risk
|
Ipilimumab and Radiotherapy (6 Gy x 2)
n=6 participants at risk
|
Ipilimumab and Radiotherapy (6 Gy x 3)
n=6 participants at risk
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
16.7%
1/6
|
0.00%
0/4
|
16.7%
1/6
|
0.00%
0/6
|
|
Immune system disorders
Cytokine release syndrome
|
16.7%
1/6
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/6
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
0.00%
0/6
|
0.00%
0/4
|
16.7%
1/6
|
0.00%
0/6
|
|
Vascular disorders
Hypotension
|
16.7%
1/6
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/6
|
|
Infections and infestations
Wound infection
|
16.7%
1/6
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/6
|
|
General disorders
|
66.7%
4/6
|
25.0%
1/4
|
33.3%
2/6
|
33.3%
2/6
|
Other adverse events
| Measure |
Ipilimumab and Radiotherapy (8 Gy x 2)
n=6 participants at risk
|
Ipilimumab and Radiotherapy (8 Gy x 3)
n=4 participants at risk
|
Ipilimumab and Radiotherapy (6 Gy x 2)
n=6 participants at risk
|
Ipilimumab and Radiotherapy (6 Gy x 3)
n=6 participants at risk
|
|---|---|---|---|---|
|
Metabolism and nutrition disorders
Anorexia
|
16.7%
1/6
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
1/6
|
0.00%
0/4
|
16.7%
1/6
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
2/6
|
0.00%
0/4
|
16.7%
1/6
|
0.00%
0/6
|
|
General disorders
Edema limbs
|
33.3%
2/6
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/6
|
|
General disorders
Fatigue
|
33.3%
2/6
|
0.00%
0/4
|
33.3%
2/6
|
0.00%
0/6
|
|
Gastrointestinal disorders
Nausea
|
33.3%
2/6
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
1/6
|
0.00%
0/4
|
16.7%
1/6
|
0.00%
0/6
|
|
Gastrointestinal disorders
Stomach pain
|
16.7%
1/6
|
0.00%
0/4
|
16.7%
1/6
|
0.00%
0/6
|
|
General disorders
|
66.7%
4/6
|
75.0%
3/4
|
100.0%
6/6
|
100.0%
6/6
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place