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

NCT ID: NCT01497808

Last Updated: 2021-08-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-29
• Study Completion Date: 2015-10-12

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

Conditions

Metastatic Melanoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ipilimumab and Radiotherapy (8 Gy x 2)

Group Type: EXPERIMENTAL

Ipilimumab

Intervention Type: DRUG

Stereotactic Body Radiation Therapy

Intervention Type: RADIATION

Ipilimumab and Radiotherapy (8 Gy x 3)

Group Type: EXPERIMENTAL

Ipilimumab

Intervention Type: DRUG

Stereotactic Body Radiation Therapy

Intervention Type: RADIATION

Ipilimumab and Radiotherapy (6 Gy x 2)

Group Type: EXPERIMENTAL

Ipilimumab

Intervention Type: DRUG

Stereotactic Body Radiation Therapy

Intervention Type: RADIATION

Ipilimumab and Radiotherapy (6 Gy x 3)

Group Type: EXPERIMENTAL

Ipilimumab

Intervention Type: DRUG

Stereotactic Body Radiation Therapy

Intervention Type: RADIATION

Interventions

Ipilimumab

Intervention Type: DRUG

Stereotactic Body Radiation Therapy

Intervention Type: RADIATION

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amit Maity, PhD

Role: PRINCIPAL_INVESTIGATOR

Abramson Cancer Center at Penn Medicine

Locations

Abramson Cancer Center of the Universirty of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

References

Maity A, Mick R, Rengan R, Mitchell TC, Amaravadi RK, Schuchter LM, Pryma DA, Patsch DM, Maity AP, Minn AJ, Vonderheide RH, Lukens JN. A stratified phase I dose escalation trial of hypofractionated radiotherapy followed by ipilimumab in metastatic melanoma: long-term follow-up and final outcomes. Oncoimmunology. 2021 Jan 31;10(1):1863631. doi: 10.1080/2162402X.2020.1863631.

Reference Type: DERIVED

PMID: 33643689 (View on PubMed)

Other Identifiers

UPCC 06611

Identifier Type: -

Identifier Source: org_study_id