Heat and immune boost: new combo tackles Hard-to-Treat cancers
NCT ID NCT03993678
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This trial tested a two-step treatment for people with advanced solid tumors that no longer respond to standard therapies. First, a laser heats and destroys part of the tumor. Then, a drug called IP-001 is injected directly into the treated area to help the immune system recognize and attack remaining cancer cells throughout the body. The study enrolled 28 adults with various cancers, including melanoma and soft tissue sarcoma, to check safety and early signs of effectiveness.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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28 people
The number who actually took part.
- Started
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Oct 2020
- Finished
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Jul 2025
- 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: * Written informed consent according to Swiss law and ICH/GCP regulations before registration. * Part 1: - 'All comer' Patients with either histologically or cytologically confirmed advanced or recurrent solid tumor cancer who failed standard therapy, are not eligible for standard therapy, or for whom no effective standard therapy is available and not requiring fast responses. * Part 2, Cohort 1 - Sarcoma cohort: Patients with either histologically or cytologically confirmed advanced or recurrent soft tissue sarcoma who failed standard therapy, are not eligible for standard therapy or for whom no effective standard therapy is available. * Part 2, Cohort 2 - Melanoma cohort: Patients with either histologically or cytologically confirmed advanced or recurrent melanoma who failed standard therapy (including a BRAF inhibitor for BRAF-mutant patients), are not eligible for standard therapy or for whom no effective standard therapy is available and have LDH \< ULN. * Presence of at least one tumor lesion that is laser ablation-accessible, with a minimum size of 1.0 cm and located (typically subcutaneously) that it can be treated with Ablation + IP-001 without risk of skin necrosis or serious damage to other adjacent vital and healthy tissue. This tumor lesion may either belong to the skin, lymph nodes, muscles or subcutaneous tissue. * Measurable or evaluable disease, determined with the most suitable imaging method (CT, PET-CT or MRI), according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. * No evidence of CNS progression for at least 4 weeks after completion of CNS-directed therapy as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period. * Age ≥ 18 years * WHO performance status 0-2 * Bone marrow function: neutrophil count ≥ 1.5 x 109/L, platelet count ≥ 100 x 109/L, hemoglobin ≥ 90 g/L * Hepatic function: bilirubin ≤ 1.5 x ULN, aspartate transaminase (AST) and alanine transaminase ALT ≤ 2.5 x ULN (or ≤ 5 x ULN in presence of liver metastasis) * Renal function: estimated glomerular filtration rate (eGFR) \> 30 mL/min/1.73m2 (according to Chronic Kidney Disease - Epidemiology Collaboration (CKD-EPI) formula) * Women with child-bearing potential are using effective contraception, are not pregnant or lactating and agree not to become pregnant during trial treatment and for an additional 90 days after the last dose of investigational drug. Women of childbearing potential must have a negative serum human chorionic gonadotropin (hCG) pregnancy test before inclusion. * Men agree not to donate sperm or to father a child during trial treatment and until 90 days after the last dose of investigational drug. Exclusion criteria * Malignant primary brain tumors, or clinically unstable symptoms from brain metastases or leptomeningeal disease, indicative of active disease. * Patients who have received chemotherapy, radiotherapy, immunotherapy, or concurrent or recent treatment with any other investigational agents within 21 days (7 days for single fraction of palliative radiotherapy, 42 days for nitrosoureas or mitomycin C) prior to registration. * Patients who have not recovered to ≤ CTCAE grade 1 from all side effects of prior therapies except for residual toxicities, such as alopecia, which do not pose an ongoing medical risk. * Patients with a previously treated malignancy, when the risk of the prior malignancy interfering with either safety or efficacy endpoints is not very low. * Patients with prostate cancer must have discontinued anti-androgens (e.g., bicalutamide, nilutamide) for at least 6 weeks prior to registration; chemical castration with luteinizing hormone-releasing hormone analogues must be continued or patients must be surgically castrated. * Concomitant treatment with systemic corticosteroids (daily dose of 10 mg prednisolone or equivalent is allowed) or other immunosuppressive therapy (e.g. methotrexate). * Oral anti-coagulation with vitamin K antagonists (e.g. phenprocoumon, warfarin) and heparin, including therapeutically dosed low molecular weight heparins (LMWH) which cannot be stopped 24 hours prior to trial treatment (low dose aspirin allowed) and bleeding diathesis * Severe or uncontrolled cardiovascular disease (congestive heart failure New York Heart Association classificationIII or IV), unstable angina pectoris, history of myocardial infarction within the last six months, serious arrhythmias requiring medication (with exception of atrial fibrillation or paroxysmal supraventricular tachycardia), significant QT-prolongation, uncontrolled hypertension . * Known history of human immunodeficiency virus (HIV) or active chronic Hepatitis C or Hepatitis B Viral infection or any uncontrolled active systemic infection (\> CTCAE grade 2) requiring intravenous (iv) antimicrobial treatment * Serious autoimmune disease (e.g. systemic lupus erythematodes) which is judged to reduce an anti-tumor immune response. * Known allergic reaction to shellfish, crabs, crustaceans, or any trial components, including medical device, used in trial treatment. * Any other serious underlying medical, psychological, familial or geographical condition, which in the judgment of the investigator may limit compliance with the planned staging, treatment and follow-up, or place the patient at high risk from treatment-related complications.
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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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Inselspital, Bern
Bern, CH-3010, Switzerland
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Kantonsspital Graubünden
Chur, 7000, Switzerland
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Kantonsspital St. Gallen
Sankt Gallen, CH-9007, Switzerland
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Other studies related to the condition(s) this trial covers.
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