Freezing cancer cells: could cryoablation boost immunotherapy?
NCT ID NCT04150939
First seen Jun 27, 2026 · Last updated Aug 07, 2026 · Updated 2 times
Summary
This study tests whether adding cryoablation—a procedure that freezes and kills cancer cells—can improve the effectiveness of standard immunotherapy in people with metastatic cancer. Fifteen participants will receive both treatments, and researchers will measure how many patients see their tumors shrink or disappear. The goal is to see if this combination can better control the disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- cryoablation (freezing tumors) plus standard immunotherapy
- What this could lead to
- If it works, this could point toward a way to boost the effectiveness of immunotherapy for people with metastatic cancer.
- What could go wrong
- This is a very small early-phase trial with only 15 participants, so results may not apply broadly. The added procedure carries risks like infection or damage to nearby tissue.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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15 people
The number who actually took part.
- Started
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Dec 2019
- Expected to finish
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Aug 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patient must have histologically or cytologically confirmed metastatic cancer and be receiving standard of care immunotherapy (PD1/PD-L1 based therapy alone or in combination with other agents (i.e. chemotherapy, targeted therapy, CTLA-4 agent) * Patient must have had \>= 70% of planned dosing schedule of PD1/PD-L1 based therapy over the prior treatment period, defined as the previous 3 months * For example, the expected number of doses in three months for nivolumab dosed every 2 weeks would be 6 infusions. If the patient were able to receive 5 out of the 6 doses (83% of planned dosing schedule), they would be eligible for the protocol. If the patient received only 4 out of the planned 6 doses (67% of planned dosing schedule), they would be ineligible for the protocol * Immunotherapy treatment must have been given within the last 4 weeks without the need for systemic steroid therapy (excluding physiologic doses not to exceed \<\<10 mg/day\>\> of prednisone or its equivalent) * Patient must have demonstrated prior clinical benefit to PD1/PD-L1 based therapy followed by progression as defined by RECIST1.1: 1) partial response (PR) or complete response (CR) by RECIST1.1 (then progression by RECIST1.1) 2) stable disease (SD) x 6 months (then progression by RECIST1.1) * Patient must have at least two lesions not previously treated with loco-regional therapy (including external beam radiation, embolization (bland or chemo), Y90, prior ablation (i.e. microwave, radiofrequency ablation, cryoablation, irreversible electroporation) that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>=10 mm with spiral computed tomography \[CT\] scan or \>= 20 mm with magnetic resonance imaging \[MRI\]) * Patient must not have a contraindication to continuing on their current immunotherapy dose regimen for at least 3 months post-cryoablation * All lines of prior therapy accepted. Patients with resections of metastatic disease will be included * Life expectancy of greater than 6 months * Eastern Cooperative Oncology Group (ECOG) performance status =\< 1 (Karnofsky \>= 70%) * Total bilirubin \< 1.5 X institutional normal limits (subjects with known Gilbert syndrome are eligible with total bilirubin \< 3.0 mg/dL) * Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 3 X institutional upper limit of normal * Creatinine within normal institutional limits OR - creatinine clearance \>= 60 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal * Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply: Women \< 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, tubal ligation or hysterectomy) * Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. Women \>= 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses \> 1 year ago, had chemotherapy-induced menopause with last menses \> 1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, tubal ligation or hysterectomy) * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Prior immune-related drug toxicity related adverse events that have not recovered to baseline or grade 1 (alopecia excluded) * Patient may not be receiving any other investigational agents * Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[e.g., colitis or Crohn's disease\], diverticulitis \[with the exception of diverticulosis\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc\]) that require treatment with a disease modifying agent. * The following are exceptions: * Patients with the above disorders may be considered upon principal investigator (PI) review and allowance (i.e. patient had an autoimmune or inflammatory disorder but despite the diagnosis has been tolerating immunotherapy) * Patients with vitiligo or alopecia * Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement * Any chronic skin condition that does not require systemic therapy * Patients without active disease in the last 5 years may be included but only after consultation with the study physician * Patients with celiac disease controlled by diet alone * Current use of immunosuppressive medication including for the treatment of severe immune toxicity related to PD1/PD-L1 based therapy that precludes further treatment with immunotherapy agents. The following are exceptions to this criterion: * Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection) * Systemic corticosteroids at physiologic doses not to exceed \<\<10 mg/day\>\> of prednisone or its equivalent * Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication) * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, interstitial lung disease, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * History of active primary immunodeficiency * Pregnant or nursing women; women of childbearing potential unless using effective contraception as determined by the investigator * Receipt of a live vaccine within 30 days of study entry * Any concurrent hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer related conditions (e.g. hormone replacement therapy) is acceptable * Patient who does not have lesions suitable for biopsy and cryoablation or measurable disease (non-ablated lesion) * The lesion being considered for cryoablation must not have undergone prior local therapy (radiation treatment, embolization (including bland embolization or chemoembolization), yttrium therapy, prior ablation of any modality (microwave, radiofrequency ablation, cryoablation, irreversible electroporation) * Patient with symptomatic central nervous system (CNS) brain metastases, craniospinal metastases, uncontrolled seizure disorder, or active neurological disease. Patients presenting with brain metastases must be asymptomatic or treated and stable off steroids and anti-convulsants for at least 1 month prior to study treatment * Patient with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen * Contraindication to enhanced magnetic resonance imaging (MRI) or computerized tomography (CT) imaging (according to patient characteristics and investigator decision) * Absolute contraindication or known untreatable allergic reactions to contrast media agents * History of allogenic organ transplantation * Known active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis (TB) testing in line with local practice), hepatitis B (known positive hepatitis B \[HBV\] surface antigen \[HBsAg\] result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \[anti-HBc\] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV ribonucleic acid (RNA)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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M D Anderson Cancer Center
Houston, Texas, 77030, United States
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