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A Phase I/II trial of MK-3475 (pembrolizumab) in children's solid tumors and lymphoma
EU CTIS ID: 2022-501257-36-00
What this study is testing
1. To define the rate of DLTs at the MTD or MAD of pembrolizumab when administered as monotherapy to children from 6 months to <18 years of age pooled across all indications including advanced melanoma, or a PD-L1 positive advanced, relapsed, or refractory solid tumor or other lymphoma. 2. To determine the safety and tolerability of pembrolizumab based on AEs and clinical and laboratory measures in children from 6 months to <18 years of age pooled across cohorts. 3. To evaluate antitumor activity of pembrolizumab in children from 6 months to <18 years of age within each tumor type including advanced melanoma, or a PD-L1 positive advanced, relapsed, or refractory solid tumor or other lymphoma, based on response RECIST 1.1 per site assessment. 4. To evaluate antitumor activity of pembrolizumab in children 6 months to <18 years within each cohort of advanced, relapsed, or refractory MSI-H or TMB-H (non-MSI-H) solid tumor based on ORR according to RECIST 1.1 per site assessment. 5. To determine the safety and tolerability of pembrolizumab based on AEs and clinical and laboratory measures in children with rrcHL. 6. To evaluate antitumor activity of pembrolizumab in the rrcHL Cohort based on the ORR per BICR assessment according to the IWG 2007 response criteria, based on assessments every 12 weeks. 7. To assess the safety and tolerability of adjuvant treatment of pembrolizumab.
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Between 6 months and <18 years of age on day of signing informed consent is documented.
- 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 last dose of study intervention
- 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.
- 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 standard therapy is considered appropriate
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 an investigational device within 4 weeks of the date of allocation/randomization
- 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 protein-4 [CTLA-4], OX-40, CD137)
- Human immunodeficiency virus (HIV)
See the full eligibility criteria
- Between 6 months and <18 years of age on day of signing informed consent is documented.
- 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 last dose of study intervention
- 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.
- 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 standard therapy is considered appropriate
- 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
- 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 allocation/randomization
- 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 protein-4 [CTLA-4], OX-40, CD137)
- 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 eligible as long as there are no symptoms of Graft Versus Host Disease [GVHD].)
- 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 interfere with the participant's participation for the full duration of the study
- 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
- Known psychiatric or substance abuse disorders that would interfere with the requirements of the study
- 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, cervical carcinoma in situ) with potentially curative therapy, or in situ cervical cancer
- 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) is acceptable
The study team makes the final eligibility decision.
Where it's taking place
- Israel
- Korea, Democratic People's Republic of
- New Zealand
- Australia
- Brazil
- Canada
- United Kingdom
- 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, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Israel; Korea, Democratic People's Republic of; New Zealand; Australia; Brazil; Canada and 2 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 EU CTIS; the study team decides eligibility.