Metastatic Melanoma
Conditions
Keywords
previously untreated, previously treated, bone, lung, liver or subcutaneous involvement, nodal involvement, without evidence of brain involvement
Brief summary
The primary objective is to determine the maximum tolerated hypofractionated radiotherapy dose (MTD) to a solitary metastatic focus ('index lesion') when followed by ipilimumab, in metastatic melanoma patients without brain involvement The secondary objectives are to determine late toxicity, immune-related clinical responses and immune pharmacodynamic changes after hypofractionated radiotherapy followed by ipilimumab
Interventions
DRUGIpilimumab
RADIATIONStereotactic Body Radiation Therapy
Sponsors
Abramson Cancer Center at Penn Medicine
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient \> 18 years old * Histologically confirmed diagnosis of melanoma * Previously treated or previously untreated metastatic melanoma by AJCC staging criteria * Presence of an index lesion \> 1 cm amenable to hypofractionated radiotherapy and at least one other additional lesion that can be followed for response using RECIST criteria * ECOG Performance status 0 or 1 * Signed informed consent document * Ability to tolerate stereotactic body radiation therapy (e.g. lie flat and hold position for treatment)
Exclusion criteria
* Prior systemic therapy within 14 days of study enrollment. Patients must be adequately recovered from prior systemic therapy side effects as deemed by the PI. * Clinical contraindication to stereotactic body radiotherapy (e.g. active systemic sclerosis, active inflammatory bowel disease if bowel is within target field, etc) * Presence or history of central nervous system metastasis (including brain) * Long-term use of systemic corticosteroids * Prior RT that precludes the delivery of hypofractionated radiotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-limiting Toxicity (DLT) | 30 days |
Secondary
| Measure | Time frame |
|---|---|
| Participants With Adverse Events | after 30 days |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ipilimumab and Radiotherapy (8 Gy x 2) Ipilimumab
Stereotactic Body Radiation Therapy | 6 |
| Ipilimumab and Radiotherapy (8 Gy x 3) | 4 |
| Ipilimumab and Radiotherapy (6 Gy x 2) | 6 |
| Ipilimumab and Radiotherapy (6 Gy x 3) | 6 |
| Total | 22 |
Baseline characteristics
| Characteristic | Ipilimumab and Radiotherapy (8 Gy x 2) | Ipilimumab and Radiotherapy (8 Gy x 3) | Ipilimumab and Radiotherapy (6 Gy x 2) | Ipilimumab and Radiotherapy (6 Gy x 3) | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 1 Participants | 4 Participants | 6 Participants | 14 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 3 Participants | 2 Participants | 0 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 4 Participants | 6 Participants | 6 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 6 Participants | 4 Participants | 6 Participants | 6 Participants | 22 Participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 1 Participants | 1 Participants | 5 Participants |
| Sex: Female, Male Male | 5 Participants | 2 Participants | 5 Participants | 5 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 4 | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 5 / 6 | 3 / 4 | 6 / 6 | 6 / 6 |
| serious Total, serious adverse events | 5 / 6 | 1 / 4 | 3 / 6 | 2 / 6 |
Outcome results
Primary
Dose-limiting Toxicity (DLT)
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ipilimumab and Radiotherapy (8 Gy x 2) | Dose-limiting Toxicity (DLT) | 0 Participants |
| Ipilimumab and Radiotherapy (8 Gy x 3) | Dose-limiting Toxicity (DLT) | 0 Participants |
| Ipilimumab and Radiotherapy (6 Gy x 2) | Dose-limiting Toxicity (DLT) | 0 Participants |
| Ipilimumab and Radiotherapy (6 Gy x 3) | Dose-limiting Toxicity (DLT) | 0 Participants |
Secondary
Participants With Adverse Events
Time frame: after 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ipilimumab and Radiotherapy (8 Gy x 2) | Participants With Adverse Events | 6 Participants |
| Ipilimumab and Radiotherapy (8 Gy x 3) | Participants With Adverse Events | 4 Participants |
| Ipilimumab and Radiotherapy (6 Gy x 2) | Participants With Adverse Events | 6 Participants |
| Ipilimumab and Radiotherapy (6 Gy x 3) | Participants With Adverse Events | 6 Participants |