RADVAX™: A STRATIFIED PHASE I/II DOSE ESCALATION TRIAL OF HYPOFRACTIONATED RADIOTHERAPY FOLLOWED BY IPILIMUMAB IN METASTATIC MELANOMA

• Sponsor: Abramson Cancer Center of the University of Pennsylvania (Other)
• Overall Status: Completed
• CT.gov ID: NCT01497808
• Collaborator: (none)
• Enrollment: 22
• Location: 1
• Arms: 4
• Actual Duration (Months): 46.4
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Metastatic Melanoma	Drug: Ipilimumab; Radiation: Stereotactic Body Radiation Therapy	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 22 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: RADVAX™: A STRATIFIED PHASE I/II DOSE ESCALATION TRIAL OF HYPOFRACTIONATED RADIOTHERAPY FOLLOWED BY IPILIMUMAB IN METASTATIC MELANOMA
• Actual Study Start Date: Nov 29, 2011
• Actual Primary Completion Date: Dec 29, 2013
• Actual Study Completion Date: Oct 12, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ipilimumab and Radiotherapy (8 Gy x 2)	Drug: Ipilimumab; Radiation: Stereotactic Body Radiation Therapy
Experimental: Ipilimumab and Radiotherapy (8 Gy x 3)	Drug: Ipilimumab; Radiation: Stereotactic Body Radiation Therapy
Experimental: Ipilimumab and Radiotherapy (6 Gy x 2)	Drug: Ipilimumab; Radiation: Stereotactic Body Radiation Therapy
Experimental: Ipilimumab and Radiotherapy (6 Gy x 3)	Drug: Ipilimumab; Radiation: Stereotactic Body Radiation Therapy

Outcome Measures

Primary Outcome Measures

1. Dose-limiting Toxicity (DLT) [30 days]

Secondary Outcome Measures

1. Participants With Adverse Events [after 30 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Abramson Cancer Center of the Universirty of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• Abramson Cancer Center of the University of Pennsylvania

Investigators

• Principal Investigator: Amit Maity, PhD, Abramson Cancer Center of the University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abramson Cancer Center of the University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT01497808
• Other Study ID Numbers: UPCC 06611
• First Posted: Dec 23, 2011
• Last Update Posted: Aug 10, 2021
• Last Verified: Jul 1, 2021

• Keywords provided by Abramson Cancer Center of the University of Pennsylvania: previously untreated; previously treated; bone, lung, liver or subcutaneous involvement; nodal involvement; without evidence of brain involvement
• Additional relevant MeSH terms: Melanoma; Ipilimumab

Study Results

Participant Flow

Arm/Group Title	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)
Arm/Group Description	Ipilimumab Stereotactic Body Radiation Therapy
Period Title: Overall Study
STARTED	6	4	6	6
COMPLETED	6	4	6	6
NOT COMPLETED	0	0	0	0

Baseline Characteristics

Arm/Group Title	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
Arm/Group Description	Ipilimumab Stereotactic Body Radiation Therapy	Total of all reporting groups
Overall Participants	6	4	6	6	22
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	3 50%	3 75%	2 33.3%	0 0%	8 36.4%
>=65 years	3 50%	1 25%	4 66.7%	6 100%	14 63.6%
Sex: Female, Male (Count of Participants)
Female	1 16.7%	2 50%	1 16.7%	1 16.7%	5 22.7%
Male	5 83.3%	2 50%	5 83.3%	5 83.3%	17 77.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%	0 0%	0 0%
Not Hispanic or Latino	6 100%	4 100%	6 100%	6 100%	22 100%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%	0 0%	0 0%
White	6 100%	4 100%	6 100%	6 100%	22 100%
More than one race	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Dose-limiting Toxicity (DLT)
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	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)
Arm/Group Description	Ipilimumab Stereotactic Body Radiation Therapy
Measure Participants	6	4	6	6
Count of Participants [Participants]	0 0%	0 0%	0 0%	0 0%

2. Secondary Outcome

Title	Participants With Adverse Events
Time Frame	after 30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	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)
Arm/Group Description	Ipilimumab Stereotactic Body Radiation Therapy
Measure Participants	6	4	6	6
Count of Participants [Participants]	6 100%	4 100%	6 100%	6 100%

Adverse Events

Arm/Group Title	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)
Arm/Group Description
All Cause Mortality
	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)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/4 (0%)		0/6 (0%)		0/6 (0%)
Serious Adverse Events
	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)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/6 (83.3%)		1/4 (25%)		3/6 (50%)		2/6 (33.3%)
Blood and lymphatic system disorders
Anemia	1/6 (16.7%)		0/4 (0%)		1/6 (16.7%)		0/6 (0%)
Gastrointestinal disorders
Gastric hemorrhage	0/6 (0%)		0/4 (0%)		1/6 (16.7%)		0/6 (0%)
General disorders
	4/6 (66.7%)		1/4 (25%)		2/6 (33.3%)		2/6 (33.3%)
Immune system disorders
Cytokine release syndrome	1/6 (16.7%)		0/4 (0%)		0/6 (0%)		0/6 (0%)
Infections and infestations
Wound infection	1/6 (16.7%)		0/4 (0%)		0/6 (0%)		0/6 (0%)
Vascular disorders
Hypotension	1/6 (16.7%)		0/4 (0%)		0/6 (0%)		0/6 (0%)
Other (Not Including Serious) Adverse Events
	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)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/6 (83.3%)		3/4 (75%)		6/6 (100%)		6/6 (100%)
Gastrointestinal disorders
Nausea	2/6 (33.3%)		0/4 (0%)		0/6 (0%)		0/6 (0%)
Stomach pain	1/6 (16.7%)		0/4 (0%)		1/6 (16.7%)		0/6 (0%)
General disorders
Edema limbs	2/6 (33.3%)		0/4 (0%)		0/6 (0%)		0/6 (0%)
Fatigue	2/6 (33.3%)		0/4 (0%)		2/6 (33.3%)		0/6 (0%)
	4/6 (66.7%)		3/4 (75%)		6/6 (100%)		6/6 (100%)
Metabolism and nutrition disorders
Anorexia	1/6 (16.7%)		0/4 (0%)		0/6 (0%)		0/6 (0%)
Respiratory, thoracic and mediastinal disorders
Cough	1/6 (16.7%)		0/4 (0%)		1/6 (16.7%)		0/6 (0%)
Dyspnea	2/6 (33.3%)		0/4 (0%)		1/6 (16.7%)		0/6 (0%)
Skin and subcutaneous tissue disorders
Pruritus	1/6 (16.7%)		0/4 (0%)		1/6 (16.7%)		0/6 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.