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New treatment option for Melanoma
Official title A Study of Pembrolizumab (MK-3475) in Pediatric Participants With an Advanced Solid Tumor or Lymphoma (MK-3475-051/KEYNOTE-051)
ClinicalTrials.gov ID: NCT02332668
What this study is testing
What is Pembrolizumab?
Pembrolizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for melanoma.
Also referred to as MK-3475.
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
- Researchers are looking for new ways to treat children with different types of melanoma (skin cancer), solid tumors, and lymphomas (blood cancers) that are any of these: Advanced, which means cancer spread in the body or cannot be removed with surgery Relapsed, which means cancer has come back after it had responded to previous treatment (responded means it stopped growing, gets smaller, or disappeared) Refractory, which means cancer did not respond to previous treatment Pembrolizumab is an immunotherapy, which is a treatment that helps the immune system fight cancer. Researchers want to learn if different doses of pembrolizumab can cause at least 1 of the types of cancer to get smaller or go away.
- 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 6 to 17
You may be able to join if
- Between 6 months and \<18 years of age on day of signing informed consent is documented.
- Histologically- or cytologically-documented, locally-advanced, or metastatic solid malignancy or lymphoma that is incurable and has failed prior...
- Any number of prior treatment regimens
- Tissue (or lymph node biopsy for rrcHL participants) available from an archival tissue sample or, if appropriate, a newly obtained core or excisional...
- Advanced melanoma or PD-L1-positive advanced, relapsed, or refractory solid tumor or lymphoma
You likely can't join if
- Currently participating and receiving study therapy in, or has participated in a study of an investigational agent and received study therapy or used...
- Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the date of...
- Prior systemic anti-cancer therapy including investigational agent within 2 weeks prior to study Day 1 or not recovered from adverse events due to a...
- Prior radiotherapy within 2 weeks of start of study treatment
- Known additional malignancy that is progressing or requires active treatment with the exception of basal cell carcinoma of the skin, squamous cell...
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
See the full eligibility criteria
- Between 6 months and \<18 years of age on day of signing informed consent is documented.
- Histologically- or cytologically-documented, locally-advanced, or metastatic solid malignancy or lymphoma that is incurable and has failed prior standard therapy, or for which no standard therapy exists, or for which no...
- Any number of prior treatment regimens
- Tissue (or lymph node biopsy for rrcHL participants) available from an archival tissue sample or, if appropriate, a newly obtained core or excisional biopsy of a tumor lesion not previously irradiated
- Advanced melanoma or PD-L1-positive advanced, relapsed, or refractory solid tumor or lymphoma
- Measurable disease based on RECIST 1.1 (Or based on IWG [Cheson, 2007] [i.e., measurement must be \>15 mm in longest diameter or \>10 mm in short axis] for rrcHL participants)
- Participants with neuroblastoma with only metaiodobenzylguanidine (MIBG)-positive evaluable disease may be enrolled
- Lansky Play Scale ≥50 for participants from 6 months up to and including 16 years of age; or Karnofsky score ≥50 for participants \>16 years of age
- Adequate organ function
- Female participants of childbearing potential should have a negative urine or serum pregnancy test within 72 hours before the first dose of study medication
- Female participant is not a woman of childbearing potential (WOCBP) or is a WOCBP who is abstinent from heterosexual intercourse or using contraception during the intervention period and for at least 120 days after the...
- Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Demonstrate adequate organ function.
- Currently participating and receiving study therapy in, or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the date of...
- Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the date of allocation/randomization
- Prior systemic anti-cancer therapy including investigational agent within 2 weeks prior to study Day 1 or not recovered from adverse events due to a previously administered agent
- Prior radiotherapy within 2 weeks of start of study treatment
- Known additional malignancy that is progressing or requires active treatment with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ (eg, breast carcinoma...
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Tumor(s) involving the brain stem
- Severe hypersensitivity (≥ Grade 3) to pembrolizumab and/or any of its excipients
- Active autoimmune disease that has required systemic treatment in past 2 years; replacement therapy (such as thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency)...
- Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
- Active infection requiring systemic therapy
- Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial through 120 days after the last dose of study medication
- Prior therapy with an anti-programmed cell death (PD)-1, anti-PD-ligand 1 (anti-PD-L1), anti-PD-L2 agent, or any agent directed to another stimulatory or inhibitory T-cell receptor (eg, cytotoxic lymphocyte associated...
- Human immunodeficiency virus (HIV)
- Hepatitis B or C
- Known history of active tuberculosis (TB; Bacillus tuberculosis)
- Received a live vaccine within 30 days of planned start of study medication
- Has undergone solid organ transplant at any time, or prior allogeneic hematopoietic stem cell transplantation within the last 5 years. (Participants who have had an allogeneic hematopoietic transplant \>5 years ago are...
- History or current evidence of any condition, therapy, or laboratory abnormality, or known severe hypersensitivity to any component or analog of the trial treatment, that might confound the results of the trial, or...
- Known psychiatric or substance abuse disorders that would interfere with the requirements of the study
The study team makes the final eligibility decision.
Where it's taking place
- Aurora, Colorado, United States
- Chicago, Illinois, United States
- Boston, Massachusetts, United States
- New York, New York, United States
- Fargo, North Dakota, United States
- Sioux Falls, South Dakota, United States
- Dallas, Texas, United States
- São Paulo, Brazil
- Paris, France
- München, Germany
- Hod HaSharon, Israel
- Rome, Italy
- Paço de Arcos, Portugal
- Seoul, South Korea
- Stockholm, Sweden
- London, United Kingdom
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, 6 months to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aurora, Colorado, United States; Chicago, Illinois, United States; Boston, Massachusetts, United States; New York, New York, United States; Fargo, North Dakota, United States; Sioux Falls, South Dakota, United States and 10 more location(s). 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.