Uveal MelanomaPhase 2NCT05077280
A Study of Concurrent Stereotactic Body Radiotherapy With Opdualag in Metastatic Uveal Melanoma
A Phase 2 study testing stereotactic body radiotherapy and Immunotherapy in people with Uveal Melanoma, run by California Pacific Medical Center Research Institute at 1 site in United States.
Trial summary
This is a phase 2 trial of concurrent stereotactic radiation therapy (SBRT) with immunotherapy with relatlimab and nivolumab for up to two years. SBRT will be given in three doses of 15Gy each to 1-5 separate metastases. Opdualag (nivolumab 480mg and relatlimab 160mg) will be given every 4 weeks for two years Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uveal Melanoma
- What is being tested?
- stereotactic body radiotherapy and Immunotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2021to Mar 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- measurable metastatic uveal melanoma.
- No concomitant therapy.
- Prior PD1 or tebendafesp allowed.
- Performance status 0-1.
- No active Hepatitis B.
- No known HIV infection.
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- WBC>2000, ANC>1500, Hgb >8.
- Creatinine < 3 x ULN.
- AST \& ALT < 2.5 x ULN Bilirubin < 2 x ULN.
- Albumin >2.9
Who cannot join
- Liver tumor volume > 50%.
- Active CNS metastases.
- Pregnancy.
- Prior therapy with Opdualag or relatlimab
- Certain autoimmune diseases.
- Previous liver embolization or radiation.
- Use of systemic steroids
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
California Pacific Medical Center Research Institute
San Francisco, California, 94115
Madeline Decker, 415-600-3613, KimB@sutterhealth.org
Kevin B Kim, M.D.
About this study
Official title: A Phase II Study of Concurrent Stereotactic Body Radiotherapy With Relatlimab and Nivolumab in Patients With Metastatic Uveal Melanoma
This is a phase 2 trial of concurrent stereotactic radiation therapy (SBRT) with immunotherapy with relatlimab and nivolumab for up to two years. SBRT will be given in three doses of 15Gy each to 1-5 separate metastases. Opdualag (nivolumab 480mg and relatlimab 160mg) will be given every 4 weeks for two years
Read the detailed description
Metastatic uveal melanoma has no standard therapy, but there is evidence that both radiation therapy and immunotherapy may be helpful and may be synergistic. This is a phase 2 trial of concurrent stereotactic radiation therapy (SBRT) with immunotherapy with Opdualag (nivolumab 480mg and relatlimab 160mg) for up to two years. SBRT will be given in three doses of 15Gy each to 1-5 separate metastases, limiting the total dosage to 700cc's of normal liver to <15Gy. Opdualag (nivolumab 480mg and relatlimab 160mg) will be given every 4 weeks for two years. Objectives are to determine the safety and tolerability, and iRECIST will be used to determine responses.We will treat up to 50 patients.
- Conditions
- Uveal Melanoma
- Being tested
- stereotactic body radiotherapy, Immunotherapy
- Keywords
- metastatic
- Medical subject headings
- Uveal Melanoma, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stereotactic body radiotherapyRadiation
Stereotactic Body radiotherapy will be given to 1-5 target metastases in 3 doses over 8 days or less. Each dose will be 15Gy for a total dose of 45GY
ImmunotherapyDrug
Opdualag (nivolumab 480mg and relatlimab 160mg) will be given every 4 weeks for two years
| Study group | Role | What they receive |
|---|---|---|
| one arm | Experimental | see below Receives: Radiation: stereotactic body radiotherapy; Drug: Immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety and tolerability of the therapy
toxicity measured by CTAE graded 3-5 toxicities
Measured: 5 years
Secondary outcomes (1)
Response rate
iRECIST defined response rates
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2021
- Study start20 Sep 2021
- Primary completionMar 2024 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uveal MelanomaStudies of the same condition, open and under way.
- 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- California Pacific Medical Center Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David R Minor, MD, Study chair, California Pacific Med Center Research Inst.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05077280
- Sponsor's protocol ID
- 2021.072-2
- Status last verified
- Dec 2022
- First submitted
- 5 Oct 2021
- Last updated
- 6 Dec 2022
- 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 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Concurrent Stereotactic Body Radiotherapy With Relatlimab and Nivolumab in Patients With Metastatic Uveal Melanoma
- ClinicalTrials.gov ID
- NCT05077280
- Acronym / sponsor ID
- 2021.072-2
- Conditions
- Uveal Melanoma
- Keywords
- metastatic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- California Pacific Medical Center Research InstituteUniversity, hospital or other
- Study start
- 20 Sep 2021 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 14 Oct 2021 (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.
This is a phase 2 trial of concurrent stereotactic radiation therapy (SBRT) with immunotherapy with relatlimab and nivolumab for up to two years. SBRT will be given in three doses of 15Gy each to 1-5 separate metastases. Opdualag (nivolumab 480mg and relatlimab 160mg) will be given every 4 weeks for two years
Detailed description
Metastatic uveal melanoma has no standard therapy, but there is evidence that both radiation therapy and immunotherapy may be helpful and may be synergistic. This is a phase 2 trial of concurrent stereotactic radiation therapy (SBRT) with immunotherapy with Opdualag (nivolumab 480mg and relatlimab 160mg) for up to two years. SBRT will be given in three doses of 15Gy each to 1-5 separate metastases, limiting the total dosage to 700cc's of normal liver to <15Gy. Opdualag (nivolumab 480mg and relatlimab 160mg) will be given every 4 weeks for two years. Objectives are to determine the safety and tolerability, and iRECIST will be used to determine responses.We will treat up to 50 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| one arm | Experimental | Radiation: stereotactic body radiotherapy, Drug: Immunotherapysee below |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- measurable metastatic uveal melanoma.
- No concomitant therapy.
- Prior PD1 or tebendafesp allowed.
- Performance status 0-1.
- No active Hepatitis B.
Key exclusion criteria (7 listed)
- Liver tumor volume > 50%.
- Active CNS metastases.
- Pregnancy.
- Prior therapy with Opdualag or relatlimab
- Certain autoimmune diseases.
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 |
|---|---|---|
| stereotactic body radiotherapyStereotactic Body radiotherapy will be given to 1-5 target metastases in 3 doses over 8 days or less. Each dose will be 15Gy for a total dose of 45GY | Radiation | one arm |
| ImmunotherapyOpdualag (nivolumab 480mg and relatlimab 160mg) will be given every 4 weeks for two years | Drug | one arm |
Primary outcome
safety and tolerability of the therapy
Time frame: 5 years
toxicity measured by CTAE graded 3-5 toxicities
1 secondary outcome
Response rate
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2022.
- 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.
David R Minor, MD study chair
California Pacific Med Center Research Inst.
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 stereotactic body radiotherapy and Immunotherapy in people with Uveal Melanoma, run by California Pacific Medical Center Research Institute 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 10 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 6 Dec 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Madeline Decker (4156006000, KimKB@sutterhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety and tolerability of the therapy (time frame: 5 years). 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 6 Dec 2022.