A Phase 1/2 interventional study of Cryosurgery and Pembrolizumab in Stage III Cutaneous Melanoma AJCC v7, Stage IIIA Cutaneous Melanoma AJCC v7 and Stage IIIB Cutaneous Melanoma AJCC v7, sponsored by Mayo Clinic. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-12.
Sponsored by Mayo Clinic · Phase 1/2, Interventional, and Treatment
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Among 44 studies in Melanoma by Mayo Clinic — 6 open to participants now, 8 under way, none of them phase 3. Melanoma · Mayo Clinic.
Among the 44 studies in Melanoma by Mayo Clinic, this one is the 28th largest by enrollment of the 35 interventional ones that give a count, is one of 4 that started in 2017, is one of 3 in phase 1/2, and was the 26th registered.
3,372 studies on the registry are indexed under Melanoma; 580 are open to participants now.
Browse Melanoma studies →6 of the 44 studies in Melanoma by Mayo Clinic are open now, in 1 country. Recruiting first, the newest first:
Mayo Clinic · Sites in United States
Ages 18+
Mayo Clinic · Sites in United States
Ages 18+
Mayo Clinic · Sites in United States
Ages 18+
Mayo Clinic · Sites in United States
Ages 18+
Mayo Clinic · Sites in United States
Ages 16+
By country, each count listing its studies:
Of the 468 Melanoma studies recruiting now, 381 (81%) set no upper age limit and 49 (10%) stop at 75 or younger; 47 take children under 18; 29 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
44 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 23 · Phase 2 10 · Phase 4 1
First in 1998; this study’s year is marked. 4 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 7 is below the median of 40 across 2,650 interventional studies indexed under Melanoma.
Median enrollment 23 across the 35 interventional studies, 98 across the 9 observational. Of the 34 that completed or were terminated, 6 (18%) have results posted.
This tab as a report to print or save as PDF → With an account.
Mayo Clinic is the lead sponsor of 3,271 studies on the registry; 672 are open to participants now.
Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.
4 of the studies in Melanoma by Mayo Clinic that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06675643Mayo ClinicDigital Remote Monitoring of Immune Checkpoint Inhibitor Therapy Induced Toxicity Using the Vigilant App | 2027-03-15 |
| NCT06265285Mayo ClinicComparison of In-Home Versus In-Clinic Administration of Subcutaneous Nivolumab Through Cancer CARE (Connected Access and Remote Expertise) Beyond Walls (CCBW) Program | 2027-05-01 |
| NCT07285044Mayo ClinicThe Cancer Connected Access and Remote Expertise Beyond Walls Program to Provide In-Home Cancer Treatment and Improve Treatment Satisfaction in Cancer Patients Living in the Florida Panhandle and Surrounding Areas | 2027-05-15 |
| NCT00835133Mayo ClinicCollecting Blood and Tissue Samples From Family Members of Patients With Pancreatic Diseases, Pancreatic Cancer, and Melanoma | 2027-09-30 |
Add all 4 to your calendar (.ics) → With an account.
Among the 44 studies in Melanoma by Mayo Clinic, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This phase Ib/II trial studies how well dendritic cell therapy after cryosurgery in combination with pembrolizumab works in treating patients with stage III-IV melanoma that cannot be removed by surgery. Vaccines made from a person's white blood cells mixed with tumor proteins may help the body build an effective immune response to kill tumor cells. Cryosurgery, also known as cryoablation or cryotherapy, kills tumor cells by freezing them. Monoclonal antibodies, such as pembrolizumab, may block tumor growth in different ways by targeting certain cells. Giving dendritic cell therapy after cryosurgery in combination with pembrolizumab may work better in treating patients with melanoma.
PRIMARY OBJECTIVES OF PHASE I portion of the trial: To establish the safety and tolerability of the proposed treatment schedule in order to move it forward into the Phase II portion of the trial.
PRIMARY OBJECTIVES OF PHASE II portion of the trial:
I. To determine the objective response rate (ORR) of pembrolizumab combined with cryoablation and intratumoral mature dendritic cells (mDCs) in patients with metastatic melanoma that has failed to respond or has stopped responding to initial therapy with a PD-1 axis-blocking monoclonal antibody.
SECONDARY OBJECTIVES:
I. To assess the safety profile of pembrolizumab combined with cryoablation and intratumoral mDCs in patients with metastatic melanoma that have failed to respond or have stopped responding to initial therapy with a PD-1 axis-blocking monoclonal antibody.
II. To determine median progression-free survival (PFS) obtained with this approach in this patient population.
III. To determine median overall survival (OS) obtained with this approach in this patient population.
TERTIARY OBJECTIVES:
I. To quantitate tumor infiltrating lymphocytes (TILs) in tumor biopsies prior to and following cryoablation and intratumoral mDCs.
II. To measure PD-L1 levels in tumor biopsies and blood biopsies prior to and following cryoablation and to assess whether a change in PD-L1 levels differ among those patients who met the criteria for clinical benefit (progression-free and on study for at least 6 months) and those who do not.
III. To measure peripheral blood mononuclear cells (PBMC) proliferation and function after coculture with frozen tumor before and after intratumoral mDC injection.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Minimum of 3 radiographically apparent lesions such that there is:
Exclusion Criteria:
Any of the following:
Active disease such as Crohn?s disease, rheumatoid arthritis, Sjogrens? disease, systemic lupus erythematosus, or similar conditions requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease/syndrome difficult to control in the past; EXCEPTIONS (the following are allowed):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Phase I Schedule 1: Cycle length is 21 days with the exception of cycle 1 which may be extended an additional 7 days to allow for dendritic cell production. Cycle 1 Day 1: Patients undergo apheresis over 4 hours and pembrolizumab IV over 30 minutes. Cycle 2 \& Cycle 3 Day 1: Pembrolizumab 200 mg is administered by IV over 30 minutes. Cycle 2 \& Cycle 3 either Day 1 or Day 2 (within 36 hours of receiving pembrolizumab): patients undergo cryosurgery (injection of 30-60 x 10\^6 mDCs and an injection of 0.5 ml Prenar13 such that two distinct metastatic lesions are cryoablated, one during cycle 2 and the other during cycle 3. Cycle 4 Day 1 and all subsequent cycles for a maximum of 2 years: Pembrolizumab 200 mg is administered by IV over 30 minutes
Procedure: Cryosurgery · Biological: Pembrolizumab · Procedure: Pheresis · Biological: Therapeutic Autologous Dendritic Cells
Phase I Schedule -1: Cycle length is 21 days with the exception of cycle 1 which may be extended an additional 7 days to allow for dendritic cell production. Cycle 1 Day 1: Patients undergo apheresis over 4 hours and pembrolizumab IV over 30 minutes. Cycle 2 \& Cycle 3 either Day 1 or Day 2 (within 36 hours of receiving pembrolizumab): patients undergo cryosurgery (injection of 30-60 x 10\^6 mDCs and an injection of 0.5 ml Prenar13 such that two distinct metastatic lesions are cryoablated, one during cycle 2 and the other during cycle 3. Cycle 4 Day 1 and all subsequent cycles for a maximum of 2 years: Pembrolizumab 200 mg is administered by IV over 30 minutes
Procedure: Cryosurgery · Biological: Pembrolizumab · Procedure: Pheresis · Biological: Therapeutic Autologous Dendritic Cells
Regimen depends upon the results of the Phase I portion of the study.
Procedure: Cryosurgery · Biological: Pembrolizumab · Procedure: Pheresis · Biological: Therapeutic Autologous Dendritic Cells
Undergo cryosurgery
Also known as: cryoablation, cryosurgical ablation
IV
Also known as: Keytruda, Lambrolizumab, MK-3475, SCH 900475
apheresis
Also known as: Apheresis, Blood Component Removal, Collection, Apheresis/Leukapheresis, Hemapheresis
Intra-tumoral injection
Number of Participants Who Developed a DLT During the First 3 Cycles of Treatment.
The primary outcome of the Phase I portion of this trial was to establish the tolerability of the proposed treatment schedule in order to move it forward into the Phase II portion of the trial. A maximum of 6 patients was to be enrolled onto the Schedule 1. If at most one of these 6 patients developed a DLT during the first 3 treatment cycles, then Schedule #1 would be carried forward to the Phase II portion of the trial. If not, then an additional 6 patients would be treated with a modified Schedule 1 where Pembrolizumab was eliminated from cycles 2 \& 3. Dose-limiting toxicity (DLT) were defined as the following possibly, probably, or definitely related AEs to protocol therapy during first 3 treatment cycles: Grade 3+ infusion reactions, acute kidney injury, chronic kidney disease, pneumonitis; or Grade 2 infusion reactions, acute kidney injury, chronic kidney disease or pneumonitis that does not resolve to Grade 0-1 within 21 days.
Time frame: Up to 3 months (3 cycles of 21 days and an additional 7 days for Cycle 1)
Incidence of Adverse Events
Assessed using Common Terminology Criteria for Adverse Events (CTCAE).
Time frame: 30 months (through study completion)
Overall Survival
Time from registration to death due to any cause
Time frame: 30 months (through study completion)
Progression-free Survival Time
time from registration to disease progression (per RECIST criteria) or death due to any cause
Time frame: 30 months (through study completion)
This Phase I/II clinical trial was designed to identify a treatment schedule for pembrolizumab in combination with cryoablation and intra-tumoral injection of mature dendritic cells (mDCs) with an acceptable safety profile (Phase 1) and then to assess anti-tumor activity (Phase II). The trial opened to enrollment November 15, 2017. The trial closed due to poor accrual on July 21, 2021, having enrolled 7 pts onto Phase I Schedule 1 cohort. The final patient occurred June 14, 2020.
| Milestone | Treatment (Apheresis, Pembrolizumab, Cryosurgery, Mature Dendritic Cells [mDCs]) |
|---|---|
| Started | 7 |
| Completed | 7 |
| Not completed | 0 |
The primary outcome of the Phase I portion of this trial was to establish the tolerability of the proposed treatment schedule in order to move it forward into the Phase II portion of the trial. A maximum of 6 patients was to be enrolled onto the Schedule 1. If at most one of these 6 patients developed a DLT during the first 3 treatment cycles, then Schedule #1 would be carried forward to the Phase II portion of the trial. If not, then an additional 6 patients would be treated with a modified Schedule 1 where Pembrolizumab was eliminated from cycles 2 \& 3. Dose-limiting toxicity (DLT) were defined as the following possibly, probably, or definitely related AEs to protocol therapy during first 3 treatment cycles: Grade 3+ infusion reactions, acute kidney injury, chronic kidney disease, pneumonitis; or Grade 2 infusion reactions, acute kidney injury, chronic kidney disease or pneumonitis that does not resolve to Grade 0-1 within 21 days.
| Participants | Phase I Schedule 1 | Phase I Schedule 2 |
|---|---|---|
| Number of patients who developed a DLT on Schedule 1 | 0 | 0 |
| Number of patients who did not develop a DLT on Schedule 1 | 7 | 0 |
Assessed using Common Terminology Criteria for Adverse Events (CTCAE).
| Participants | Phase I Schedule 1 | Phase 1 Schedule -1 |
|---|---|---|
| grade 3 headache | 1 | — |
| grade 2 creatinine increase | 1 | — |
| grade 2 aspartate aminotransferase increase | 1 | — |
| grade 2 fatigue | 2 | — |
| grade 2 fever | 1 | — |
| grade 2 hyperglycemia | 2 | — |
| grade 2 pain | 2 | — |
| grade 3 hypertension | 1 | — |
| grade 2 blood bilirubin increase | 1 | — |
Time from registration to death due to any cause
| days | Treatment (Apheresis, Pembrolizumab, Cryosurgery, Mature Dendritic Cells [mDCs]) |
|---|---|
| Overall Survival | 211 (11 to 751) |
time from registration to disease progression (per RECIST criteria) or death due to any cause
| days | Phase I Schedule 1 | Phase I Schedule -1 | Phase II Schedule |
|---|---|---|---|
| Progression-free Survival Time | 88 (11 to 113) | — | — |
Collected over 30 months (through study completion). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Phase I Schedule 1 | 7/7 (100%) | 2/7 (28.6%) | 4/7 (57.1%) |
| Phase I Schedule -1 | — | — | — |
| Phase II Schedule | — | — | — |
| Event | Phase I Schedule 1 | Phase I Schedule -1 | Phase II Schedule |
|---|---|---|---|
| grade 3 hypertensionVascular disorders | 1/7 | — | — |
| grade 3 headacheNervous system disorders | 1/7 | — | — |
| Event | Phase I Schedule 1 | Phase I Schedule -1 | Phase II Schedule |
|---|---|---|---|
| Grade 2 fatigueGeneral disorders | 2/7 | — | — |
| Grade 2 painGeneral disorders | 2/7 | — | — |
| Grade 2 hyperglycemiaMetabolism and nutrition disorders | 2/7 | — | — |
| Grade 2 blood bilirubin increaseInvestigations | 1/7 | — | — |
| Grade 2 Aspartate aminotransferase increasedInvestigations | 1/7 | — | — |
| Grade 2 Creatinine increaseInvestigations | 1/7 | — | — |
| Grade 2 feverGeneral disorders | 1/7 | — | — |
Study closed to enrollment due to poor accrual.
| Age, Customized(years) | Phase I Schedule 1 | Phase I Schedule -1 | Phase II Schedule | Total |
|---|---|---|---|---|
| Age at study entry | 65.4 (58.4 to 76.2) | — | — | 65.4 (58.4 to 76.2) |
| Sex: Female, Male(Participants) | Phase I Schedule 1 | Phase I Schedule -1 | Phase II Schedule | Total |
|---|---|---|---|---|
| Female | 2 | — | — | 2 |
| Male | 5 | — | — | 5 |
| Ethnicity (NIH/OMB)(Participants) | Phase I Schedule 1 | Phase I Schedule -1 | Phase II Schedule | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | — | — | 0 |
| Not Hispanic or Latino | 7 | — | — | 7 |
| Unknown or Not Reported | 0 | — | — | 0 |
| Race (NIH/OMB)(Participants) | Phase I Schedule 1 | Phase I Schedule -1 | Phase II Schedule | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | — | — | 0 |
| Asian | 0 | — | — | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | — | — | 0 |
| Black or African American | 0 | — | — | 0 |
| White | 7 | — | — | 7 |
| More than one race | 0 | — | — | 0 |
| Unknown or Not Reported | 0 | — | — | 0 |
| Region of Enrollment(participants) | Phase I Schedule 1 | Phase I Schedule -1 | Phase II Schedule | Total |
|---|---|---|---|---|
| United States | 7 | — | — | 7 |
| ECOG Performance Status at Study entry(Participants) | Phase I Schedule 1 | Phase I Schedule -1 | Phase II Schedule | Total |
|---|---|---|---|---|
| ECOG PS = 0 | 5 | — | — | 5 |
| ECOG PS = 1 | 2 | — | — | 2 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Data will be shared with investigators following the policies and procedures of the Mayo Clinic Cancer Center.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Available for 10 years post study closure.
Ran from Nov 2017 to primary completion in Jun 2020, 30 months.
Results were first posted in Jun 2025, 4 years 11 months after primary completion.
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This study is terminated, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Therapeutic Autologous Dendritic Cells