NCT06952400Phase IIRecruiting
National Health Research Institutes, Taiwan · Taipei Veterans General Hospital, Taipei, Taiwan/Taipei
Cutaneous melanoma is the most aggressive malignancy in skin cancers. Cutaneous melanoma is a rare disease in Taiwan with an incidence rate of around 1/100,000. Acral lentiginous melanoma is the most common subtype and comprises more than half of cutaneous melanoma in Asia including Taiwan but only 1% in Caucasians. In addition, mucosal melanoma accounts for more than 20% of malignancy melanoma in Taiwan but only 1% in Caucasians. Acral and mucosal melanomas have distinct epidemiological, clinical, pathological and genetic features from non-acral melanoma which is commonly seen in Western countries. Comparing with melanoma in Caucasians, Asian melanoma has higher recurrence rate after primary surgery, lower response rate to immunotherapy, and shorter progression-free survival for immunotherapy and targeted therapy leading generally poor survival outcomes regardless stage.
Eligibility: 18 Years to · All · 1. Age \> 18 years old
2. Pathologically confirmed melanoma. (Patients with additional malignancies requiring treatment or follow-up are allowed. Only treatment for melanoma should be recorded).
3. ECOG performance status \< 3
4. Cohort 1(early acral melanoma): melanoma, stage I/II; Cohort 2 (locally advanced acral melanoma): melanoma, stage III, resectable; and Cohort 3 (advanced): unresectable / metastatic melanoma, stage III/IV or recurrent melanoma (unresectable). Staging is based on AJCC Cancer Staging System 8th edition). The patients with advanced melanoma with available comprehensive NGS report are included in cohort 4.
5. Willingness to provide archival or newly obtained tumor tissues for this study proposal
6. Life expectancy more than 3 months -
7. Patients fully understand the protocol with the willingness to have regular follow-up
NCT05983237Phase 1, Phase 2Recruiting
Jun Guo · Beijing Cancer Hospital, Beijing
The purpose of this study is to evaluate how well fuzoparib in combination with camrelizumab and temozolomide works in treating patients with advanced, metastatic melanoma with the homologous recombination (HR) pathway gene mutation / alteration.
Eligibility: 18 Years to · All · 1. Histologically confirmed diagnosis of unresectable or metastatic stage III or IV melanoma;
2. Must have genetic HR and/or SF3B1 mutation/ alteration;
3. Must have measurable disease based on RECIST 1.1;
4. Must have an ECOG performance status of 0 to 1;
5. Must have recovered from all AEs due to previous therapies to ≤Grade 1 or baseline;
6. Anticipated overall survival more than 3 months;
7. Male and no pregnant female, able to adapt birth control methods during treatment.
NCT07288112Phase 1, Phase 2Recruiting
Diakonos Oncology Corporation · The University of Alabama at Birmingham, Birmingham, Alabama
The goal of this clinical trial is to learn if DOC1021 + pIFN will be safe and will lead to tumor responses in patients with refractory melanoma. DOC1021 is a dendritic cell immunotherapy derived from a patient's own blood cells and loaded with antigens from the patient's tumor in the form of tumor lysate and mRNA. The goal is to stimulate a T cell immune response that eliminates tumor cells.
The study consists of two components: an initial phase I safety study to confirm safety/tolerability of the treatment regimen, and, subsequently, a single-arm phase II cohort to assess efficacy of the treatment regimen.
All participants will:
* Undergo a leukapheresis collection (take filgrastim subcutaneously x 5 doses, if clinically necessary, leading up to collection)
* Receive two doses of DOC1021 under image guidance 2 weeks apart
* Receive subcutaneous pIFN injections weekly for a total of 4 doses in parallel with the DOC1021 injections
* Undergo an optional image-guided perinodal DOC1021 booster injection approximately 6 months after the first DOC1021 dose along with additional subcutaneous pIFN injections at time of the booster and the subsequent week for a total of 2 pIFN doses
* Visit the clinic regularly to assess quality of life, symptoms, medication use, imaging, bloodwork, and to receive optional treatment with anti-PD1 agents
Eligibility: 18 Years to · All · 1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and avail-ability for the duration of the study
3. Age 18 years or older
4. Patients diagnosed with unresectable or metastatic melanoma and progressed following ≥1 prior systemic therapy including anti-PD-1 (i.e., refractory to anti-PD-1). Refractory defined as primary or secondary resistance as per SITC guidelines, except that confirmatory scan not required if clinical progression requiring surgery or radiation to relieve symptoms
5. Willing and able to withhold anti-PD-1 treatment from the time of enrollment through at least 6 weeks after the first DOC1021 administration
6. One or more lesions available for biopsy or resection expected to yield at least 50 mg and preferably 100 mg of tumor for generating DOC1021 and at least 1 measurable target tumor lesion evaluable after DOC1021 by RECIST version 1.1.
7. Brain metastases allowed if stable after prior treatment
8. Ability to receive leukapheresis (with filgrastim if clinically indicated) and perinodal injections of DOC1021 near regional nodes + weekly pIFN x 4 weeks (i.e., sufficient clinical stability and anticipated life expectancy to complete the treatment period and allow time for an immune response to develop).
9. Females of reproductive potential must have a negative serum pregnancy test and agree to use effective contraception (as deter-mined appropriate for the patient by the investigator) during study treatment.
10. Adequate kidney, liver, bone marrow function, and immune function, as follows:
1. Hemoglobin ≥ 8.0 gm/dL (use of transfusion or other intervention to achieve is acceptable)
2. Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
3. Platelet count ≥ 75,000/mm3
4. Calculated creatinine clearance (CrCl) \> 30 mL/min using Cockcroft and Gault formula:
i. For males = (140 - age\[years\]) x (body weight \[kg\]) / (72 x serum creatinine \[mg/dL\]) ii. For females = 0.85 x value from male formula e. Total bilirubin ≤ 1.5 times upper limit of normal (ULN) except in patients with Gilbert's disease for which total bilirubin must be ≤ 3 times ULN f. Aspartate transaminase AST (SGOT) and alanine aminotransferase ALT (SGPT) ≤ 3 times the ULN (or ≤ 5.0 × ULN if liver metastases)
11. Eastern Cooperative Oncology Group (ECOG) Performance Score 0 or 1
NCT07564570NARecruiting
Universitätsklinikum Hamburg-Eppendorf · University Medical Center Hamburg-Eppendorf, Hamburg, Free and Hanseatic City of Hamburg
The aim of this research project is to determine whether a short bout of physical exercise immediately before the start of immunotherapy (Nivolumab and Ipilimumab) is feasible and has a positive effect on the effectiveness of immunotherapy. It is known that short-term physical exercise leads to marked changes in the innate and adaptive immune system. These changes-specifically an increase in natural killer (NK) cells and cytotoxic T cells-are associated with a better response to immunotherapy.
The patient population selected for this study consists of patients with advanced-stage melanoma who are receiving Nivolumab and Ipilimumab.
First, we aim to assess whether such an intervention is feasible in a large proportion of patients, as many patients experience disease-related and treatment-related side effects.
Secondary objectives are to demonstrate that the exercise intervention positively influences the immune system and that this, in turn, leads to an improved response to therapy, thereby positively affecting patient survival, improving quality of life, and reducing treatment-related side effects.
Eligibility: 18 Years and older · All · * Histologically confirmed metastatic malignant melanoma with an indication for immunotherapy (Nivolumab and Ipilimumab).
* The participant provides written informed consent for the study.
* The participant is at least 18 years of age on the day the informed consent is signed.
* No prior systemic anticancer therapy for metastatic disease (e.g., cytotoxic or targeted agents).
* ECOG (Eastern Cooperative Oncology Group) performance status score of ≤ 2.
* No physical impairment that would preclude participation in physical exercise.
NCT06529822Phase 1Recruiting
Washington University School of Medicine · AdventHealth, Orlando, Florida
This is a phase 1 clinical trial to evaluate the safety, feasibility and immunogenicity of a personalized cancer vaccine strategy in patients with solid tumors and molecular residual disease. The hypothesis of the trial is that synthetic long peptide personalized cancer vaccines will be safe and capable of generating measurable neoantigen-specific T-cell responses enabling ctDNA clearance. The personalized cancer vaccines are composed of synthetic long peptides corresponding to prioritized cancer neoantigens and will be co-administered with poly-ICLC.
Eligibility: 18 Years to · All · Inclusion Criteria Cohort #1:
* Age ≥ 18 years.
* ECOG performance status ≤ 2 (Karnofsky ≥ 60%).
* Histologically confirmed muscle-invasive bladder cancer (MIBC) or upper tract urothelial carcinoma (renal pelvis and/or ureter).
* Patients with carcinomas showing mixed histologies are required to have a dominant transitional cell pattern.
* Complete surgical resection of MIBC (R0) or upper tract urothelial carcinoma (renal pelvis and/or ureter). Tumor, nodes, metastases (TNM) classification (based on the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th ed.) at pathological examination of surgical resection specimen as follows: ypT0N0M0, pT2-4N0M0, or pT0-4aN+M0.
* Patient must have fully recovered from surgical resection in the opinion of the treating MD.
* ctDNA positive result as identified by Signatera.
* Radiologic confirmation (by conventional imaging) of absence of residual disease and absence of metastasis.
* Adequate bone marrow and organ function as defined below:
* WBC ≥ 1.5 K/cumm
* Absolute neutrophil count ≥ 1.0 K/cumm
* Platelets ≥ 50 K/cumm
* Hemoglobin ≥ 8.0 g/dL
* Total bilirubin ≤ 1.5 x IULN
* AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN
* Creatinine clearance \> 30 mL/min by Cockcroft-Gault
* The effects of synthetic long peptide personalized cancer vaccines and Hiltonol on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 5 months after completion of study interventions. Should a woman become pregnant or suspect she is pregnant while participating in this study or should a man suspect he has fathered a child, s/he must inform her treating physician immediately.
* No concurrent investigational therapies outside of this protocol are allowed.
* Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.
Exclusion Criteria Cohort #1:
* Receiving any other investigational agents, or planning to receive other investigational agents as part of neoadjuvant therapy. Patients who have received perioperative neoadjuvant chemotherapy and immunotherapy, including enfortumab vedotin plus pembrolizumab (EV+P), are allowed.
* Known allergy, or history of serious adverse reaction to vaccines such as anaphylaxis, hives, or respiratory difficulty.
* A psychiatric illness or social situations that would limit compliance with study requirements as determined by the investigator from the medical history, physical exam, and/or medical record.
* Prior or currently active autoimmune disease requiring management with immunosuppression. This includes inflammatory bowel disease, ulcerative colitis, Crohn's disease, systemic vasculitis, scleroderma, psoriasis, multiple sclerosis, hemolytic anemia, immune-mediated thrombocytopenia, rheumatoid arthritis, systemic lupus erythematosus, Sjögren's syndrome, sarcoidosis, or other rheumatologic disease or any other medical condition or use of medication (e.g., corticosteroids) which might make it difficult for the patient to complete the full course of treatments or to generate an immune response to vaccines. In the case of asthma or chronic obstructive pulmonary disease taking inhaled corticosteroids that does not require daily systemic corticosteroids is acceptable. Additionally, local acting steroids (topical, inhaled, or intraarticular) will be allowed. Patients on intermittent or short course steroids will be allow if the dose does not exceed 4 mg of dexamethasone (or equivalent) per day for \> 7 consecutive days. Premedication for chemotherapy does not apply to this criterion and may be administered as per SOC practice. Any patients receiving steroids should be discussed with the PI to determine if eligible.
* Known HIV-positive status.
* History of positive test for Hep
NCT06214156Phase 1, Phase 2Recruiting
Shanghai Pharmaceuticals Holding Co., Ltd · Beijing Cancer Hospital, Beijing
This clinical study evaluated the tolerability, safety and preliminary efficacy of T3011 in subjects with advanced melanoma.
Eligibility: 18 Years to · All · 1. Subjects with advanced melanoma;
2. At least one measurable lesion;
3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
4. Expected survival \> 12 weeks;
5. Laboratory inspection meets the requirements;
6. For women of childbearing potential, the serum pregnancy test results must be negative within 7 days prior to the first dose，and effective contraceptive measures must be taken from signing the informed consent form (ICF) until at least 6 months after the last dose;
7. Male subjects of childbearing potential agree to use effective contraception from signing the ICF until at least 6 months after the last dose; In addition, male subjects must agree not to donate sperm during this period;
8. Understand and voluntarily sign the ICF，willing and able to comply with all experimental requirements.
