Metastatic MelanomaPhase 1/2NCT01497808
RADVAX™: A STRATIFIED PHASE I/II DOSE ESCALATION TRIAL OF HYPOFRACTIONATED RADIOTHERAPY FOLLOWED BY IPILIMUMAB IN METASTATIC MELANOMA
A Phase 1/2 study testing Ipilimumab and Stereotactic Body Radiation Therapy in people with Metastatic Melanoma, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Melanoma
- What is being tested?
- Ipilimumab and Stereotactic Body Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Nov 2011to 12 Oct 2015
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center of the Universirty of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
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
- Being tested
- Ipilimumab, Stereotactic Body Radiation Therapy
- Keywords
- previously untreated, previously treated, bone, lung, liver or subcutaneous involvement, nodal involvement, without evidence of brain involvement
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IpilimumabDrug
Stereotactic Body Radiation TherapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| Ipilimumab and Radiotherapy (8 Gy x 2) | Experimental | Not described Receives: Drug: Ipilimumab; Radiation: Stereotactic Body Radiation Therapy |
| Ipilimumab and Radiotherapy (8 Gy x 3) | Experimental | Not described Receives: Drug: Ipilimumab; Radiation: Stereotactic Body Radiation Therapy |
| Ipilimumab and Radiotherapy (6 Gy x 2) | Experimental | Not described Receives: Drug: Ipilimumab; Radiation: Stereotactic Body Radiation Therapy |
| Ipilimumab and Radiotherapy (6 Gy x 3) | Experimental | Not described Receives: Drug: Ipilimumab; Radiation: Stereotactic Body Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting Toxicity (DLT)
Measured: 30 days
Secondary outcomes (1)
Participants With Adverse Events
Measured: after 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2011 (estimated)
- Study start29 Nov 2011
- Primary completion29 Dec 2013
- Study completion12 Oct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic MelanomaStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amit Maity, PhD, Principal investigator, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01497808
- Sponsor's protocol ID
- UPCC 06611
- Status last verified
- Jul 2021
- First submitted
- 13 Dec 2011
- Last updated
- 10 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 33643689
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RADVAX™: A STRATIFIED PHASE I/II DOSE ESCALATION TRIAL OF HYPOFRACTIONATED RADIOTHERAPY FOLLOWED BY IPILIMUMAB IN METASTATIC MELANOMA
- ClinicalTrials.gov ID
- NCT01497808
- Acronym / sponsor ID
- UPCC 06611
- Conditions
- Metastatic Melanoma
- Keywords
- previously untreated, previously treated, bone, lung, liver or subcutaneous involvement, nodal involvement, without evidence of brain involvement
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- 29 Nov 2011 (actual)
- Primary completion
- 29 Dec 2013 (actual)
- Study completion
- 12 Oct 2015 (actual)
- First posted
- 23 Dec 2011 (estimated)
- Results
- Posted 10 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) |
Primary outcome
Dose-limiting Toxicity (DLT)
Time frame: 30 days
1 secondary outcome
Participants With Adverse Events
Time frame: after 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33643689Maity 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amit Maity, PhD principal investigator
Abramson Cancer Center at Penn Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ipilimumab and Stereotactic Body Radiation Therapy in people with Metastatic Melanoma, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting Toxicity (DLT) (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01497808, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2021.