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

NCT01497808 | Completed Phase 1 Results DMC

• 1 other identifier: UPCC 06611
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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

Keywords

previously untreated; previously treated; bone, lung, liver or subcutaneous involvement; nodal involvement; without evidence of brain involvement

Outcome Measures

Primary Outcomes (1)

• Dose-limiting Toxicity (DLT)

  30 days

Secondary Outcomes (1)

• Participants With Adverse Events

  after 30 days

Study Arms (4)

Ipilimumab and Radiotherapy (8 Gy x 2)

EXPERIMENTAL

Drug: Ipilimumab; Radiation: Stereotactic Body Radiation Therapy

Ipilimumab and Radiotherapy (8 Gy x 3)

EXPERIMENTAL

Drug: Ipilimumab; Radiation: Stereotactic Body Radiation Therapy

Ipilimumab and Radiotherapy (6 Gy x 2)

EXPERIMENTAL

Drug: Ipilimumab; Radiation: Stereotactic Body Radiation Therapy

Ipilimumab and Radiotherapy (6 Gy x 3)

EXPERIMENTAL

Drug: Ipilimumab; Radiation: Stereotactic Body Radiation Therapy

Interventions

Ipilimumab DRUG

Ipilimumab and Radiotherapy (6 Gy x 2); Ipilimumab and Radiotherapy (6 Gy x 3); Ipilimumab and Radiotherapy (8 Gy x 2); Ipilimumab and Radiotherapy (8 Gy x 3)

Stereotactic Body Radiation Therapy RADIATION

Ipilimumab and Radiotherapy (6 Gy x 2); Ipilimumab and Radiotherapy (6 Gy x 3); Ipilimumab and Radiotherapy (8 Gy x 2); Ipilimumab and Radiotherapy (8 Gy x 3)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of the Universirty of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• 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.

  PMID: 33643689 DERIVED

MeSH Terms

Conditions

Melanoma

Interventions

Ipilimumab; Radiosurgery

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Dr. Amit Maity
• Organization: University of Pennsylvania

maity@uphs.upenn.edu

(215) 615-6767

Study Officials

• Amit Maity, PhD

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2011
• First Posted: December 23, 2011
• Study Start: November 29, 2011
• Primary Completion: December 29, 2013
• Study Completion: October 12, 2015
• Last Updated: August 10, 2021
• Results First Posted: August 10, 2021

Record last verified: 2021-07

Locations

US (1)