MelanomaPhase 2NCT03126461
SAbR Plus Ipilimumab Plus Nivolumab in Metastatic Melanoma Patients
A Phase 2 study testing SAbR, Ipilimumab and Nivolumab in people with Melanoma and Metastatic Melanoma, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
A one-arm, single center phase 2 trial of SAbR plus ipilimumab plus nivolumab in advanced metastatic melanoma patients Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Melanoma, Metastatic Melanoma
- What is being tested?
- SAbR, Ipilimumab and Nivolumab
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2018to 31 Dec 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologic diagnosis of metastatic melanoma.
- Any number of prior systemic therapeutic regimens including chemotherapy, pathway inhibitors, biochemotherapy, investigational agents, and immunotherapies other than ipilimumab, nivolumab or other CTLA-4, PD-1 or PD-L1 inhibitors.
- Patients must have measurable disease in at least 2 non-radiated sites as defined by RECIST v1.1. All sites must be evaluated within 4 weeks prior to registration.
- Age ≥ 18 years.
- Eligible for SABR to 1-5 sites of disease (Refer to 3.2.10)
- Performance status ECOG 0-2.
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- Adequate organ and marrow function as defined below:
- leukocytes ≥ 1,000/mcL
- absolute neutrophil count ≥ 1,000/mcL
- platelets ≥ 75,000/mcl
- total bilirubin < 2.5X institutional upper limit of normal or
- 3 in subjects with Gilbert's Syndrome
- AST(SGOT)/ALT(SPGT) ≤ 4 X institutional upper limit of normal
- creatinine < 4X institutional upper limit of normal
- hemoglobin >7g/dL
- Ability to understand and the willingness to sign a written informed consent.
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of protocol treatment. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: has not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
Who cannot join
- No concomitant therapy with any of the following: IL2, interferon, or other non-study immunotherapy regimens; cytotoxic chemotherapy; immunosuppressive agents; or other investigational therapies; all such therapies must have been discontinued >4weeks prior to registration.
- No infection with HIV and no known history of hepatitis B or hepatitis C virus indicating acute or chronic infection or active TB.
- Patients are excluded if they have a history of any other malignancy from which the patient has been disease-free for less than 2 years, with the exception of adequately treated (Surgery or radiation) and cured basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix, or localized adenocarcinoma of the cervix.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Patients must not be pregnant or nursing.
- Patients are excluded if they have a history of prior treatment with ipilimumab, CTLA-4 inhibitor or agonist, nivolumab, PD-1 or PD-L1 inhibitor.
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- Subjects who have had major surgery within 2 weeks prior to first dose of drug
- Subjects who have had radiation therapy within 2 weeks prior to first dose of drug
- Uncontrolled adrenal insufficiency or active chronic liver disease
- Any history of CNS metastases that is not adequately treated (surgery or radiation ) >14 days prior to registration.
- Any active known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
- Any condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days prior to the first dose of study drug. Inhaled steroids and adrenal replacement steroid doses up to 10 mg daily prednisone equivalent are permitted (although not encouraged) in the absence of active autoimmune disease.
- Subjects with life expectancy < 6 months
- Subjects receiving any other investigational or standard antineoplastic agents.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, 75390
About this study
Official title: Phase 2 Trial of SAbR Plus Ipilimumab Plus Nivolumab in Metastatic Melanoma Patients
A one-arm, single center phase 2 trial of SAbR plus ipilimumab plus nivolumab in advanced metastatic melanoma patients
Read the detailed description
SAbR/GRID plus ipilimumab 3mg/kg IV q3wk x 4 plus nivolumab 1 mg/kg IV q3wk x 4, followed by nivolumab 240 mg IV q 2wk until progression or intolerable toxicity
- Conditions
- Melanoma, Metastatic Melanoma
- Being tested
- SAbR, Ipilimumab, Nivolumab
- Keywords
- metastatic melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAbRRadiation
Also called Stereotactic ablative body radiation
For patients treated on the "GRID A" regimen, a dose of 15-20 Gy will be delivered with the GRID device in either a single field, with prescription to dmax, or with parallel opposed GRID fields (matching beamlets from the opposed directions). For patients treated on the "GRID B" regimen, this same dose will be delivered, with a subsequent regimen of 3 Gy X 10 fractions, with the first of these fractions following the GRID dose.
IpilimumabDrug
Also called Yervoy®
ipilimumab 3mg/kg IV q3wk x 4
NivolumabDrug
Also called Opdivo®
nivolumab 1 mg/kg IV q3wk x 4
| Study group | Role | What they receive |
|---|---|---|
| SAbR plus ipilimumab plus nivolumab | Experimental | SAbR/GRID plus ipilimumab 3mg/kg IV q3wk x 4 plus nivolumab 1 mg/kg IV q3wk x 4, followed by nivolumab 240 mg IV q 2wk until progression or intolerable toxicity Receives: Radiation: SAbR; Drug: Ipilimumab; Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of tumor size from baseline to follow up
treatment response rate-RR based on RECISTv1.1
Measured: at 12, 24, 36 weeks
Secondary outcomes (3)
disease control rate
disease control rate defined as response plus stable disease based on RECISTv1.1
Measured: at 12, 24, 36 weeks
Number of treatment-related adverse events
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: 2 years
programmed death ligand-1 (PD-L1) expression
compare tumor PD-L1 expression at 3 time points
Measured: baseline, cycle 1 Day 1, and week 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study start1 Mar 2018 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Why it stopped: the project was never initiated and no participants were enrolled, it was closed permanently
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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 2
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kevin Albuquerque, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03126461
- Sponsor's protocol ID
- STU 082016-058
- Status last verified
- Apr 2018
- First submitted
- 23 Mar 2017
- Last updated
- 20 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Trial of SAbR Plus Ipilimumab Plus Nivolumab in Metastatic Melanoma Patients
- ClinicalTrials.gov ID
- NCT03126461
- Acronym / sponsor ID
- STU 082016-058
- Conditions
- Melanoma, Metastatic Melanoma
- Keywords
- metastatic melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: the project was never initiated and no participants were enrolled, it was closed permanently
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 1 Mar 2018 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 24 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A one-arm, single center phase 2 trial of SAbR plus ipilimumab plus nivolumab in advanced metastatic melanoma patients
Detailed description
SAbR/GRID plus ipilimumab 3mg/kg IV q3wk x 4 plus nivolumab 1 mg/kg IV q3wk x 4, followed by nivolumab 240 mg IV q 2wk until progression or intolerable toxicity
Study design
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SAbR plus ipilimumab plus nivolumab | Experimental | Radiation: SAbR, Drug: Ipilimumab, Drug: NivolumabSAbR/GRID plus ipilimumab 3mg/kg IV q3wk x 4 plus nivolumab 1 mg/kg IV q3wk x 4, followed by nivolumab 240 mg IV q 2wk until progression or intolerable toxicity |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Histologic diagnosis of metastatic melanoma.
- Any number of prior systemic therapeutic regimens including chemotherapy, pathway inhibitors, biochemotherapy, investigational agents, and immunotherapies other than ipilimumab, nivolumab or other CTLA-4, PD-1 or PD-L1 inhibitors.
- Patients must have measurable disease in at least 2 non-radiated sites as defined by RECIST v1.1. All sites must be evaluated within 4 weeks prior to registration.
- Age ≥ 18 years.
- Eligible for SABR to 1-5 sites of disease (Refer to 3.2.10)
Key exclusion criteria (14 listed)
- No concomitant therapy with any of the following: IL2, interferon, or other non-study immunotherapy regimens; cytotoxic chemotherapy; immunosuppressive agents; or other investigational therapies; all such therapies must have been discontinued >4weeks prior to registration.
- No infection with HIV and no known history of hepatitis B or hepatitis C virus indicating acute or chronic infection or active TB.
- Patients are excluded if they have a history of any other malignancy from which the patient has been disease-free for less than 2 years, with the exception of adequately treated (Surgery or radiation) and cured basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix, or localized adenocarcinoma of the cervix.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Patients must not be pregnant or nursing.
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 |
|---|---|---|
| SAbRAlso: Stereotactic ablative body radiationFor patients treated on the "GRID A" regimen, a dose of 15-20 Gy will be delivered with the GRID device in either a single field, with prescription to dmax, or with parallel opposed GRID fields (matching beamlets from the opposed directions). For patients treated on the "GRID B" regimen, this same dose will be delivered, with a subsequent regimen of 3 Gy X 10 fractions, with the first of these fractions following the GRID dose. | Radiation | SAbR plus ipilimumab plus nivolumab |
| IpilimumabAlso: Yervoy®ipilimumab 3mg/kg IV q3wk x 4 | Drug | SAbR plus ipilimumab plus nivolumab |
| NivolumabAlso: Opdivo®nivolumab 1 mg/kg IV q3wk x 4 | Drug | SAbR plus ipilimumab plus nivolumab |
Primary outcome
Change of tumor size from baseline to follow up
Time frame: at 12, 24, 36 weeks
treatment response rate-RR based on RECISTv1.1
3 secondary outcomes
disease control rate
Time frame: at 12, 24, 36 weeks
Number of treatment-related adverse events
Time frame: 2 years
programmed death ligand-1 (PD-L1) expression
Time frame: baseline, cycle 1 Day 1, and week 15
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2020.
- Individual participant dataSharing planned: No
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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.
Kevin Albuquerque, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SAbR, Ipilimumab and Nivolumab in people with Melanoma and Metastatic Melanoma, run by University of Texas Southwestern Medical Center 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 17 inclusion and 14 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: withdrawn, as of the sponsor's last update on 20 Aug 2020. 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 phase mean?
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change of tumor size from baseline to follow up (time frame: at 12, 24, 36 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Aug 2020.