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RADVAX: A Stratified Phase I/II Dose Escalation Trial of Stereotactic Body Radiotherapy Followed by Ipilimumab in Metastatic Melanoma

Phase 1/Phase 2
18 Years
Open (Enrolling)
Metastatic Melanoma

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Trial Information

RADVAX: A Stratified Phase I/II Dose Escalation Trial of Stereotactic Body Radiotherapy Followed by Ipilimumab in Metastatic Melanoma

This is a stratified phase I/II study of escalating fractions of stereotactic body
radiotherapy (SBRT) combined with immunotherapy with Ipilimumab for previously untreated or
previously treated metastatic melanoma patients who are aged 18 years or older. Phase I is
stratified by site: bone or lung versus liver or subcutaneous (s.c.) Six patients will be
enrolled per dose cohort. Phase II is stratified by prior treatment:previously untreated
for metastatic disease versus previously treated for metastatic disease. In phase II, 14
patients will be treated at the MTD (maximum tolerated dose) in each stratum of which phase
I patients treated at the site specific MTD will be included. Descriptive statistics will
be generated for both phases of the study.

Inclusion Criteria:

- Patients aged 18 years and older.

- Histologically confirmed diagnosis of melanoma

- Previously treated or previously untreated stage IV melanoma by AJCC staging criteria

- Presence of an index lesion between 1 cm and 5 cm.

- EGOC performance status 0 to 1

- Signed informed consent document.

- Adequate renal, hepatic, and hematologic indices for ipilimumab therapy

- Ability to tolerate stereotactic body radiation therapy (e.g. lie flat and hold
position for treatment)

Exclusion Criteria:

- Prior systemic therapy within 28 days of study enrollment

- Clinical contraindication to stereotactic body radiotherapy ( systemic
sclerosis, active inflammatory bowel disease if bowel is within target field, etc)

- Previous treatment with antiCTLA-4 antibody or cancer vaccine

- Presence or history of central nervous system metastasis (including brain)

- Long-term use of systemic corticosteroids

- Prior RT within 2 months of study entry

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment

Outcome Measure:

Dose-limiting toxicity (DLT)

Outcome Time Frame:

30 days

Safety Issue:


Principal Investigator

Ramesh Rengan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Abramson Cancer Center of the University of Pennsylvania


United States: Institutional Review Board

Study ID:

UPCC 06611



Start Date:

December 2011

Completion Date:

June 2014

Related Keywords:

  • Metastatic Melanoma
  • previously untreated
  • previously treated
  • bone, lung, liver or subcutaneous involvement
  • nodal involvement
  • without evidence of brain involvement
  • Melanoma



Abramson Cancer Center of the Universirty of Pennsylvania Philadelphia, Pennsylvania  19104