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New treatment option for Melanoma
Official title Metronomic Cyclophosphamide With Pembrolizumab in Checkpoint Inhibitor Refractory Melanoma
ClinicalTrials.gov ID: NCT06771544
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.
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
- This is a phase 2, single-arm, open label clinical trial determining efficacy of Cyclophosphamide and Pembrolizumab in subjects with melanoma.
- 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
- Age ≥18 years at the time of signing informed consent form (ICF)
- Patients must have unresectable Stage III or Stage IV non-ocular melanoma per American Joint Committee on Cancer 8th Edition Staging Criteria not...
- Participants must have measurable disease by RECIST v1.1 criteria as assessed by investigator/ radiology. Lesions situated in a previously irradiated...
- Participants must have Eastern Cooperative Group (ECOG) performance status score of 0, 1 or 2 at screening visit.
- Life expectancy of at least 12 weeks
You likely can't join if
- Participants with a diagnosis of ocular or metastatic uveal melanoma
- Participants with a history of a malignant disease other than those being treated in this study. The following exceptions are permitted:
- Malignancies that were treated curatively and have not recurred within 2 years. Shorter intervals can be considered after discussion with the...
- Completely resected basal cell and squamous cell skin cancers.
- Any malignancy considered to be indolent and that has never required therapy, such as chronic lymphocytic leukemia.
- Completely resected carcinoma in situ of any type
See the full eligibility criteria
Who can join
- Age ≥18 years at the time of signing informed consent form (ICF)
- Patients must have unresectable Stage III or Stage IV non-ocular melanoma per American Joint Committee on Cancer 8th Edition Staging Criteria not amenable to local therapy
- Participants must have measurable disease by RECIST v1.1 criteria as assessed by investigator/ radiology. Lesions situated in a previously irradiated area are considered measurable if progression has been shown in such...
- Participants must have Eastern Cooperative Group (ECOG) performance status score of 0, 1 or 2 at screening visit.
- Life expectancy of at least 12 weeks
- Adequate bone marrow, liver, and renal function
- Hemoglobin ≥9.0 g/dL
- Platelets ≥100/mm3
- ANC ≥1.5/mm3
- Creatinine Clearance ≥ 30mL/min Cockcroft-Gault CrCl, mL/min = (140 - age) × (weight, kg) × (0.85 if female) / (72 × Cr, mg/dL).
- AST and ALT less than 3 times the Upper Limit of Normal or less than 5 times the Upper Limit of normal with liver metastases. T Bilirubin \< 3.1 mg/dL.
- Has progressed on a prior PD-1/PD-L1 treatment
- Recovered from toxicities of pembrolizumab to Grade ≤1, excluding endocrine toxicities
- Prior Receipt of PD-1/PD-L1 therapy within 9 weeks prior to the first dose of the investigational therapy.
- Women of childbearing potential must have had a negative pregnancy test performed within 7 days prior to the start of treatment
- Females of childbearing potential and males must be willing and able to use an adequate method of contraception to avoid pregnancy for the duration of the study.
- Male and female participants of childbearing potential who are sexually active with a non-sterilized partner must agree to use highly effective methods of birth control from the trial screening date until 3 months after...
- Pregnant or lactating women are prohibited from enrolling in this study.
- Male participants are not allowed to donate sperm from the time of enrollment until 6 months after administration of study interventions.
What rules you out
- Participants with a diagnosis of ocular or metastatic uveal melanoma
- Participants with a history of a malignant disease other than those being treated in this study. The following exceptions are permitted:
- Malignancies that were treated curatively and have not recurred within 2 years. Shorter intervals can be considered after discussion with the Principal Investigator.
- Completely resected basal cell and squamous cell skin cancers.
- Any malignancy considered to be indolent and that has never required therapy, such as chronic lymphocytic leukemia.
- Completely resected carcinoma in situ of any type
- Participants ineligible to be retreated with pembrolizumab due to a treatment-related AE while on a prior anti-PD(L)-1 regimen that led to discontinuation of that prior therapy and would thus prevent retreatment or with...
- Participants with known untreated or symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis. NOTE: Participants with previously treated brain metastases may participate provided ALL of the...
- Treated CNS lesions are radiographically stable (without evidence of progression for ≥ 28 days prior to the first dose of study intervention) after intervention (eg, surgery and/or radiation).
- Neurologically stable and on stable dose of ≤ 10mg of prednisone equivalent steroids for at least 7 days prior to the first dose of study intervention.
- Any prior investigational or standard cancer therapy, with exception of PD-1/PD-L1 (includes nivolumab + Relatlimab) therapy, chemotherapy or radiation within 6-9 weeks of the first dose of the investigational therapy...
- Presence of B-RAF driver mutation without prior receipt of BRAF +/- MEK inhibitors, unless patient declines BRAF +/-MEK inhibition for any reason or is unable to tolerate BRAF and/or MEK inhibitors.
- Participants with a known history of chronic viral infections as indicated below. If patients do not have a known history, testing is not required during the screening period to confirm the patient has an active...
- Known HBV infection defined as hepatitis B surface antigen reactive. NOTE: Participants with HBV infection on stable anti-viral therapy for \> 4 weeks prior to the planned first study intervention and viral load...
- Known active HCV infection defined as detectable HCV RNA (qualitative) infection. NOTE: History of HCV is not exclusionary if participant has received curative treatment and viral load is confirmed as undetectable...
- Active HIV infection. Those with HIV infections on combination antiretroviral medications with stable CD4 count \>200/microliters as measured within screening time period. If the patient does not have a known history of...
- Positive serum pregnancy test
- Participants with out-of-range screening laboratory values as defined below. NOTE: Hematology evaluations must be performed \>7 days from any blood transfusion. Or blood product transfusion or from any dose of...
- Glomerular filtration rate (calculated using the Chronic Kidney Disease Epidemiology Collaboration formula) \< 30 mL/min
- Total bilirubin \> 1.5 × ULN; participants with Gilbert's syndrome are excluded if total bilirubin \> 3.0 × ULN; or direct bilirubin \> 1.5 × ULN
- Albumin \< 3.0 g/dL
- Absolute lymphocyte count \< 0.5 × 10\^9/L
- Participants with a history of allogeneic tissue/solid organ transplant
The study team makes the final eligibility decision.
Where it's taking place
- Orange, California, 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 Orange, California, 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.