High Risk MelanomaPhase 1NCT01996202
A Pilot Study of Ipilumimab and Radiation in Poor Prognosis Melanoma
A Phase 1 study testing Ipilumimab and Radiation in people with High Risk Melanoma, run by Duke University at 1 site in United States.
Trial summary
This is a pilot study assessing the safety of the combination of ipilimumab administered concurrently with radiotherapy for patients with locally advanced or unresectable melanoma and patients at high risk for recurrence after resection. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- High Risk Melanoma
- What is being tested?
- Ipilumimab and Radiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Sep 2018
- Phase
- Phase 1
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to give written informed consent.
- Histologic diagnosis of melanoma
- Cohort 1: Resected patients at high risk of recurrence. Patients must meet at least one of the following criteria
- Melanoma of mucosal origin b. Desmoplastic melanoma c. Primary melanoma of the head or neck with any lymph node involvement d. Patients with non-head and neck primaries must have had preoperative/pathologic macroscopic lymph node involvement, defined by clinically evident on exam or imaging evaluation, plus at least one of the following by clinical, imaging, or pathologic evaluation: i. ≥ 2 cervical or axillary nodes ii. ≥ 3 groin lymph nodes iii. Extracapsular extension (ECE) of tumor iv. Lymph nodes ≥ 3cm
- Cohort 2: Neoadjuvant/definitive approach for locally advanced patients. Patients must meet at least one of the following criteria
- Melanoma of mucosal origin
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- Desmoplastic melanoma
- Patients with radiographic evidence of tumor invasion into surrounding local structures rendering them inoperable
- Macroscopic nodal involvement. In addition, patients must also meet one of the following criteria
- Recurrent disease, with any number and size of nodes ii. ≥ 1 parotid node(s) iii. ≥ 2 cervical or axillary nodes iv. ≥ 3 groin lymph nodes v. Lymph nodes ≥ 3cm vi. ECE of tumor
- Resected patients should begin treatment within 12 weeks of surgery, once adequately healed as determined by the treating physicians.
- Local-regional treatment sites must be able to be encompassed within a reasonable radiation therapy treatment volume
- Patients with recurrent disease are allowed in cohort 1, provided at least one of the criteria listed in 3 above is met
- For patients with a new diagnosis of melanoma treated in cohort 2 who have a cutaneous primary, the primary site may be addressed surgically (wide local excision; skin grafting) prior to the initiation of ipilimumab and radiation at the discretion of the treating surgeon.
- Required values for initial laboratory tests:
- WBC ≥ 2000/uL
- ANC ≥ 1000/uL
- Platelets ≥ 75 x 103/uL
- Hemoglobin ≥ 9 g/dL (≥ 80 g/L; may be transfused)
- Creatinine ≤ 2.0 x ULN
- AST/ALT ≤ 2.5 x ULN
- Bilirubin ≤ 2.0 x ULN, (except patients with Gilbert's Syndrome, who must have a total bilirubin less than 3.0 mg/dL)
- No active or chronic infection with HIV, Hepatitis B, or Hepatitis C.
- ECOG performance status ≤ 1
- Men and women, ≥ 18 years of age
- Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 26 weeks after the last dose of investigational product, in such a manner that the risk of pregnancy is minimized
- WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not post-menopausal. Post-menopause is defined as:
- Amenorrhea ≥ 12 consecutive months without another cause, or
- For women with irregular menstrual periods and taking hormone replacement therapy (HRT), a documented serum follicle stimulating hormone (FSH) level ≥ 35 mIU/mL.
- Women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where their partner is sterile (eg, vasectomy) should be considered to be of childbearing potential.
- WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours before the start of ipilimumab.
- Men of fathering potential must be using an adequate method of contraception to avoid conception throughout the study [and for up to 26 weeks after the last dose of investigational product] in such a manner that the risk of pregnancy is minimized.
- Patients must agree to blood sampling to participate in study.
Who cannot join
- Ocular melanoma
- Presence of brain metastases
- Prior radiation therapy for melanoma
- Any other malignancy form which the patient has been disease-free for less than 3 years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix, or DCIS. Patients with prior malignancies that are not considered to be an active problem may be enrolled at the discretion of the investigator, regardless of time frame.
- Autoimmune disease: Patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn's Disease, are excluded from this study, as are patients with a history of symptomatic disease (eg, rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [eg, Wegener's Granulomatosis]); motor neuropathy considered of autoimmune origin (e.g. Guillain-Barre Syndrome and Myasthenia Gravis).
- Any underlying medical or psychiatric condition, which in the opinion of the investigator will make the administration of ipilimumab hazardous or obscure the interpretation of AEs, such as a condition associated with frequent diarrhea.
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- Any non-oncology vaccine therapy used for prevention of infectious diseases (for up to 1 month before or after any dose of ipilimumab).
- A history of prior treatment with ipilimumab or prior CD137 agonist or CTLA 4 inhibitor or agonist.
- Concomitant therapy with any of the following: IL 2, interferon, or other non-study immunotherapy regimens; cytotoxic chemotherapy; immunosuppressive agents; other investigation therapies; or chronic use of systemic corticosteroids in the previous 4 weeks (defined as prednisone 10mg daily or equivalent.)
- Women of childbearing potential (WOCBP), defined above in Section 4.1, who:
- are unwilling or unable to use an acceptable method of contraception to avoid pregnancy for their entire study period and for at least 26 weeks after cessation of study drug, or
- have a positive pregnancy test at baseline, or
- are pregnant or breastfeeding.
- Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (eg, infectious) illness.
- Persons of reproductive potential must agree to use an adequate method of contraception throughout treatment and for at least 26 weeks after ipilimumab is stopped. Sexually active WOCBP must use an effective method of birth control during the course of the study, in a manner such that risk of failure is minimized. Before study enrollment, WOCBP must be advised of the importance of avoiding pregnancy during study participation and the potential risk factors for an unintentional pregnancy. All WOCBP MUST have a negative pregnancy test before first receiving ipilimumab. If the pregnancy test is positive, the patient must not receive ipilimumab and must not be enrolled in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
This is a pilot study assessing the safety of the combination of ipilimumab administered concurrently with radiotherapy for patients with locally advanced or unresectable melanoma and patients at high risk for recurrence after resection.
- Conditions
- High Risk Melanoma
- Being tested
- Ipilumimab, Radiation
- Keywords
- Melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IpilumimabDrug
RadiationRadiation
| Study group | Role | What they receive |
|---|---|---|
| Resected Melanoma | Other | Subjects with resected melanoma. Receives: Drug: Ipilumimab; Radiation: Radiation |
| Unresected Melanoma | Other | Subjects with unresected melanoma. Receives: Drug: Ipilumimab; Radiation: Radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of immune related adverse events associated with ipilimumab
Measured: 2 years
Incidence of acute and late radiation toxicities
Measured: 2 years
Secondary outcomes (6)
Overall response rate (ORR)
Measured: 2 years
6 month progression free survival (PFS)
Measured: 6 months
12 month progression free survival (PFS)
Measured: 12 months
Overall survival
Measured: 2 years
CD4+ and CD8+ reactivity to melanoma tumor antigens
Measured: 2 years
Cytokines associated with anti-tumor response
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionSep 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Risk MelanomaStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01996202
- Sponsor's protocol ID
- Pro00045042
- Status last verified
- Jul 2019
- First submitted
- 22 Nov 2013
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Ipilumimab and Radiation in Poor Prognosis Melanoma
- ClinicalTrials.gov ID
- NCT01996202
- Acronym / sponsor ID
- Pro00045042
- Conditions
- High Risk Melanoma
- Keywords
- Melanoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 27 Nov 2013 (estimated)
- 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 pilot study assessing the safety of the combination of ipilimumab administered concurrently with radiotherapy for patients with locally advanced or unresectable melanoma and patients at high risk for recurrence after resection.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resected Melanoma | Other | Drug: Ipilumimab, Radiation: RadiationSubjects with resected melanoma. |
| Unresected Melanoma | Other | Drug: Ipilumimab, Radiation: RadiationSubjects with unresected melanoma. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (33 listed)
- Willing and able to give written informed consent.
- Histologic diagnosis of melanoma
- Cohort 1: Resected patients at high risk of recurrence. Patients must meet at least one of the following criteria
- Cohort 2: Neoadjuvant/definitive approach for locally advanced patients. Patients must meet at least one of the following criteria
- Resected patients should begin treatment within 12 weeks of surgery, once adequately healed as determined by the treating physicians.
Key exclusion criteria (15 listed)
- Ocular melanoma
- Presence of brain metastases
- Prior radiation therapy for melanoma
- Any other malignancy form which the patient has been disease-free for less than 3 years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix, or DCIS. Patients with prior malignancies that are not considered to be an active problem may be enrolled at the discretion of the investigator, regardless of time frame.
- Autoimmune disease: Patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn's Disease, are excluded from this study, as are patients with a history of symptomatic disease (eg, rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [eg, Wegener's Granulomatosis]); motor neuropathy considered of autoimmune origin (e.g. Guillain-Barre Syndrome and Myasthenia Gravis).
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 |
|---|---|---|
| Ipilumimab | Drug | Resected Melanoma, Unresected Melanoma |
| Radiation | Radiation | Resected Melanoma, Unresected Melanoma |
Primary outcome
Incidence of immune related adverse events associated with ipilimumab
Time frame: 2 years
Incidence of acute and late radiation toxicities
Time frame: 2 years
6 secondary outcomes
Overall response rate (ORR)
Time frame: 2 years
6 month progression free survival (PFS)
Time frame: 6 months
12 month progression free survival (PFS)
Time frame: 12 months
Overall survival
Time frame: 2 years
CD4+ and CD8+ reactivity to melanoma tumor antigens
Time frame: 2 years
Cytokines associated with anti-tumor response
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ipilumimab and Radiation in people with High Risk Melanoma, run by Duke University 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 33 inclusion and 15 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 5 Jul 2019. 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 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.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of immune related adverse events associated with ipilimumab (time frame: 2 years). The study lists 2 primary outcomes in all. 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 5 Jul 2019.