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New treatment option for Metastatic Melanoma
Official title Ipilumumab and Nivolumab With or Without Hypofractionated Radiotherapy in Patients With Metastatic Melanoma
ClinicalTrials.gov ID: NCT03646617
What this study is testing
What is Nivolumab?
Nivolumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for metastatic melanoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The main purpose of this study is to determine the safety of combining ipilimumab and nivolumab with hypofractionated radiotherapy to a single tumor in patients with metastatic melanoma. Another purpose of this study is to determine the effect of ipilimumab, nivolumab and hypofractionated radiotherapy on the cancer as compared to ipilimumab and nivolumab.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically confirmed metastatic melanoma.
- Have at least two measurable lesions (including the index lesion) according to RECIST (Response Evaluation Criteria in Solid Tumours)guidelines v1.1.
- Have an index lesion measuring between 1cm - 7cm that is amenable to hypofractionated radiation therapy (HFRT) at the discretion of the treating...
- Able to tolerate HFRT (e.g. lie flat and hold position for treatment)
- Able to provide signed, written informed consent and age \> 18 years at time of signing
You likely can't join if
- Central nervous system (CNS) metastases requiring urgent local therapy; patients with carcinomatous meningitis are excluded. If there is clinical...
- Concurrent enrollment in another clinical study, unless in a follow-up period or the study is an observational or non-treatment study.
- Prior therapy with an anti-PD-1 (including nivolumab), anti-programmed death ligand (anti-PD-L1, anti-PDL2, or anti-CTLA4 (including ipilimumab)...
- Concurrent treatment with any anticancer agent, including chemotherapy, immunotherapy, or biologic therapy.
- Treatment with any other investigational agent within 4 weeks prior to first dose of nivolumab/ipilimumab.
- Prior chemotherapy, targeted small molecule therapy or other anti-cancer therapy within 2 weeks prior to first dose of nivolumab/ipilimumab or who...
See the full eligibility criteria
Who can join
- Histologically confirmed metastatic melanoma.
- Have at least two measurable lesions (including the index lesion) according to RECIST (Response Evaluation Criteria in Solid Tumours)guidelines v1.1.
- Have an index lesion measuring between 1cm - 7cm that is amenable to hypofractionated radiation therapy (HFRT) at the discretion of the treating radiation oncologist
- Able to tolerate HFRT (e.g. lie flat and hold position for treatment)
- Able to provide signed, written informed consent and age \> 18 years at time of signing
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Recovery from the adverse effects of prior cancer treatments, defined as effects having resolved to NCI CTCAE v5 Grade 1 or better with the exception of alopecia. people with irreversible toxicity that is not reasonably...
- Female people of childbearing potential must have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as...
- Female people of childbearing potential must be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for two weeks before the time of the first dose of study...
- Non-sterilized male people must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy. Acceptable forms of birth control...
- Demonstrate adequate organ function; all screening labs should be performed within 21 days of date of consent.
- White blood cell \>= 2,500 cells/ul
- Absolute neutrophil count (ANC) ≥1,500 /mcL
- Platelets \>=100,000 / mcL
- Hemoglobin \>=9 g/dL
- Serum creatinine OR Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) \ =60 mL/min for subject with creatinine levels \> 1.5 X institutional ULN (Creatinine clearance...
- Serum total bilirubin \<= 1.5 X ULN OR
- Direct bilirubin \ 1.5 ULN
- AST (SGOT) and ALT (SGPT) \<= 2.5 X ULN OR \<= 5 X ULN for people with liver metastases
What rules you out
- Central nervous system (CNS) metastases requiring urgent local therapy; patients with carcinomatous meningitis are excluded. If there is clinical suspicion of brain metastases, a brain MRI should be obtained.
- Concurrent enrollment in another clinical study, unless in a follow-up period or the study is an observational or non-treatment study.
- Prior therapy with an anti-PD-1 (including nivolumab), anti-programmed death ligand (anti-PD-L1, anti-PDL2, or anti-CTLA4 (including ipilimumab) agents, interferon, HD IL-2 or any other antibody or drug specifically...
- Concurrent treatment with any anticancer agent, including chemotherapy, immunotherapy, or biologic therapy.
- Treatment with any other investigational agent within 4 weeks prior to first dose of nivolumab/ipilimumab.
- Prior chemotherapy, targeted small molecule therapy or other anti-cancer therapy within 2 weeks prior to first dose of nivolumab/ipilimumab or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events...
- Known hypersensitivity to nivolumab, ipilimumab, monoclonal antibodies or immunoglobulin G.
- Major surgical procedure (as defined by the investigator) within 28 days prior to the first dose of nivolumab/ipilimumab or still recovering from prior surgery
- Current or prior use of immunosuppressive medication within 14 days before the first dose of nivolumab/ipilimumab with the exceptions of intranasal, topical and inhaled corticosteroids, systemic corticosteroids at...
- Active or prior documented autoimmune disease (including inflammatory bowel disease, diverticulitis with the exception of diverticulosis, celiac disease, irritable bowel disease, Wegner syndrome, Hashimoto syndrome)...
- History of primary immunodeficiency or tuberculosis.
- Known true positive results for HIV or known active Hepatitis B (e.g. HBsAg reactive) or Hepatitis C (e.g. HCV RNA [qualitative] is detected) as determined by medical record review.
- Receipt of a live, attenuated vaccine within 28 days prior to the first dose of nivolumab/ipilimumab. (NOTE: people, if enrolled, should not receive live vaccine during the study or for 180 days after the last dose of...
- Clinical contraindication to hypofractionated radiation as determined by the investigator (e.g., active systemic sclerosis, active inflammatory bowel disease if bowel is within radiation field.)
- Prior radiotherapy that precludes the proposed treatment with HFRT or any radiotherapy within 28 days of first dose of nivolumab/ipilimumab.
- Females who are pregnant, lactating, or intend to become pregnant during the participation of the study.
- Uncontrolled inter-current illness, including, but not limited to, ongoing or active infection, current pneumonitis, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac...
- Other active invasive malignancy. History of non-invasive malignancies such as cervical carcinoma in situ, non-melanomatous carcinoma of the skin, or ductal carcinoma in situ of the breast is allowed, as is history of...
- Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results
The study team makes the final eligibility decision.
Where it's taking place
- Lancaster, Pennsylvania, United States
- Philadelphia, Pennsylvania, United States
- Salt Lake City, Utah, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lancaster, Pennsylvania, United States; Philadelphia, Pennsylvania, United States; Salt Lake City, Utah, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.