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Clinical Trial Finder

Search Results

Adjuvant Nivolumab & Low Dose Ipilimumab for Stage III & Resected Stage IV Melanoma

Study Purpose

Effective adjuvant treatment can increase cure in patients with high-risk resected melanoma. High dose interferon is a standard of care in the adjuvant setting but is highly toxic and marginally effective. The combination of ipilimumab and nivolumab is the most active regimen in patients with advanced melanoma so there is clear rationale to test this regimen in the adjuvant setting. Investigators are testing if nivolumab 3mg/kg every 2 weeks with 1mg/kg ipilimumab every 6 weeks in the high risk adjuvant setting. The duration of therapy will be six months.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Histologically or cytologically proven melanoma.
The primary site of melanoma may be cutaneous on other body site such as ocular or anorectal. Documentation required to be sent to BrUOG.
  • - Completely resected stage III (lymph node positive) or resected stage IV disease.
Patients with stage T4BN0 are also eligible. It is required that patients with stage IIIA disease have > 1mm nodal involvement via pathology assessment of the resected node. All patients must be disease free to be eligible.
  • - No prior treatment for melanoma other than surgical resection or radiation.
At least 4 weeks since prior surgery and 3 weeks since prior radiation to registration date.
  • - Age >/= 18 years.
  • - ECOG performance status 0-1.
  • - Patients must have organ and marrow function as defined below within 14 days of study entry: Hematologic Absolute neutrophil count (ANC) >/= 1.5 X 109/L; Hemoglobin >/= 9.5 g/dL; Platelets >/= 100 X 109/L; Total Bilirubin ≤ 1.5 x ULN except subjects with normal direct bilirubin or those with known Gilbert's syndrome.
Send information to BrUOG if patient has known Gilbert's syndrome AST and ALT /= 2.5 g/dL Renal Creatinine OR Calculated creatinine clearance : Creatinine 50ml/min.
  • - No clinically significant coagulation disorder as defined by the treating MD.
Therapeutic use of anticoagulants is permissible. Add to concomitant medication log if applicable.
  • - Not pregnant and not nursing.
Women of child bearing potential must have a negative serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 7 days prior to Day 1 of treatment. Post-menopausal women (surgical menopause or lack of menses >12 months) do not need to have a pregnancy test, please document status.
  • - Confirmation of informed consent.
  • - Men and women of childbearing potential enrolled in this study must agree to use adequate barrier birth control measures during the course of the study and up to 2 months after end of treatment.

Exclusion Criteria:

  • - Currently receiving cancer therapy (chemotherapy, radiation therapy, immunotherapy, or biologic therapy) or investigational anti-cancer drug.
  • - Brain metastases, whether resected or not, and any known leptomeningeal disease or known bone metastases.
  • - Pregnant or breastfeeding female.
  • - Unwillingness or inability to follow the procedures required in the protocol, to document.
  • - Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results.
  • - Prior malignancy active within the previous 2 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.
Documentation required to be sent to BrUOG.
  • - Subjects with active, known or suspected autoimmune disease.
Subjects with vitiligo, controlled 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.
  • - Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration.
Inhaled or topical steroids and adrenal replacement doses >10mg daily of prednisone equivalents are permitted in the absence of active autoimmune disease.
  • - Prior treatment with an anti-PD-1, anti-PD-L1 or anti-CTLA-4 antibody.
  • - Any positive test result for hepatitis B or C virus indicating acute or chronic infection.
  • - Known history of testing positive for human immunodeficiency virus or known acquired immunodeficiency syndrome.
  • - History of severe hypersensitivity reaction to any monoclonal antibody.
  • - Patients with unstable angina (anginal symptoms at rest) or new-onset angina (began within the last 3 months) or myocardial infarction within the past 6 months.
- History of autologous transplant or organ allograft even if not taking immunosuppressive medications

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02656706
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Brown University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Howard Safran, MD
Principal Investigator Affiliation BrUOG Study Chair
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Active, not recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Melanoma
Additional Details

See above summary

Arms & Interventions

Arms

Experimental: Adjuvant treatment

Ipilumumab:1mg/kg q6weeks (1 dose per cycle, 4 planned treatments over 6 months total) Nivolumab:3mg/kg q2weeks (3 doses per cycle, 12 planned treatments over 6 months total)

Interventions

Drug: - Ipilumumab

Drug: - Nivolumab

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Providence, Rhode Island

Status

Address

Rhode Island Hospital and The Miriam Hospital

Providence, Rhode Island, 02903/02906

Nearest Location


Resources

  • Patient and Caregiver Survey
  • Clinical Trial Endpoints
  • Research Resources
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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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