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Monthly Update Report for Trials Started in December 2025


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1: Summary data from new trials identified for Melanoma.


Overview

Number of Trials: 8

These eight trials span diverse oncology settings, including advanced melanoma, breast cancer, non-small cell lung cancer, and other solid tumors. Several trials test immunotherapy combinations (nivolumab, ipilimumab, pembrolizumab, tebentafusp) in metastatic or recurrent melanoma, while others evaluate novel agents (JMT108, AMXT 1501 + DFMO, capivasertib) in advanced solid tumors. One trial assesses home-based cancer therapy delivery, another examines surgical management in elderly melanoma patients, and one focuses on wound healing post-Mohs surgery. Common themes include immune checkpoint modulation, targeted therapy for genomic alterations, and improving treatment access or outcomes in specific populations.

Common Criteria Across Trials

Common Inclusion

  • Age ≥18 years
  • ECOG performance status 0–2
  • Adequate organ function (hematologic, hepatic, renal)
  • Histologically or cytologically confirmed malignancy
  • Measurable or evaluable disease
  • Negative pregnancy test for women of childbearing potential
  • Willingness to use contraception
  • Ability to provide informed consent

Common Exclusion

  • Active or uncontrolled infection
  • Active autoimmune disease requiring systemic immunosuppression
  • Known brain metastases (unless treated and stable)
  • Pregnant or breastfeeding
  • Prior severe hypersensitivity to study drugs
  • Concurrent investigational agents
  • Uncontrolled intercurrent illness
  • Active secondary malignancy
  • HIV with detectable viral load, active hepatitis B or C

2: Extracted Trials with New Information


Trials with Special Criteria

Genomic / Biomarker Trials

Unique or Unusual Criteria

Trials with Emerging Treatments


3: Individual Trial Overviews


NCT07276386

Phase 2 Sequential Treatment With Melphalan/HDS Via Percutaneous Hepatic Perfusion Followed by Tebentafusp in the Treatment of Metastatic Uveal Melanoma Genomic-based

Organization/Sponsor: H. Lee Moffitt Cancer Center and Research Institute


Example patient: A 52-year-old HLA-A*02:01-positive woman with ECOG 1 performance status and biopsy-confirmed uveal melanoma metastatic to liver involving 40% of liver volume, with no extrahepatic disease and adequate cardiac and hepatic function.

Phase 2

Interventions

  • Biologic: Tebentafusp
    Summary: Bispecific T cell engager that binds gp100 peptide-HLA complexes on tumor cells and CD3 on T cells to redirect immune attack against uveal melanoma. FDA-approved for HLA-A*02:01-positive unresectable or metastatic uveal melanoma. Sources: FDA label, NCI Thesaurus.
  • Procedure with Drug: Melphalan/HDS (Percutaneous Hepatic Perfusion)
    Summary: Minimally invasive procedure delivering high-dose melphalan chemotherapy directly to liver via hepatic artery with extracorporeal filtration of hepatic venous blood. Melphalan is a bifunctional alkylating agent that damages DNA to inhibit tumor growth. Sources: FDA label, NCI Thesaurus.

Key Inclusion

  • Age ≥18 years
  • HLA-A*02:01 positive status
  • Histologically or cytologically confirmed liver metastasis of uveal melanoma
  • Measurable disease by CT per RECIST 1.1 with at least one target lesion in liver
  • ECOG performance status 0 or 1
  • Patient deemed suitable for PHP and tebentafusp
  • Limited extrahepatic disease treatable with SBRT or surgical resection allowed
  • Adequate contraception required for 150 days after last dose

Key Exclusion

  • More than 50% liver volume replaced by tumor
  • Untreatable extrahepatic disease
  • Active cardiac conditions or heart failure precluding general anesthesia
  • Severe pulmonary disease precluding general anesthesia
  • Reduced hepatic function (AST, ALT, bilirubin >2.5×ULN, PT-INR >1.5) or liver cirrhosis
  • Active autoimmune disease requiring systemic immunosuppressive treatment
  • Corticosteroids >10 mg daily prednisone equivalents within 14 days
  • Previous treatment with PHP or tebentafusp

NCT07032701

Assessing the Impact of a Disposable Negative Pressure Wound Therapy Device on Surgical Wounds of the Lower Extremities Following Mohs Micrographic Surgery

Organization/Sponsor: Jonsson Comprehensive Cancer Center


Example patient: A 65-year-old non-smoking patient without diabetes or vascular disease presents with a 10 cm lower leg wound after Mohs surgery for basal cell carcinoma, capable of managing home wound care.

Phase N/A

Interventions

  • Device: Negative Pressure Wound Therapy
    Summary: A wound dressing system that continuously or intermittently applies subatmospheric pressure to draw out fluid and promote healing in surgical wounds (NCI Thesaurus).
  • Procedure: Best Practice
    Summary: Standard wound care treatment expected to be helpful for lower extremity wounds following Mohs surgery (NCI Thesaurus).
  • Other: Questionnaire Administration
    Summary: Collection of patient-reported outcomes through structured questionnaires (NCI Thesaurus).
  • Other: Photography
    Summary: Wound imaging to document healing progress over time (NCI Thesaurus).
  • Other: Follow-Up Care
    Summary: Clinical monitoring following wound treatment to assess healing outcomes (NCI Thesaurus).
  • Other: Educational Intervention
    Summary: Patient education on home-based wound care and device management (NCI Thesaurus).

Key Inclusion

  • Aged 19 to 79 years
  • Lower limb wound following Mohs surgery for non-melanoma skin cancer
  • Wound designated to heal by secondary intention
  • Wound size less than 13 cm x 13 cm
  • Patient capable of changing SNAP-therapy system at home

Key Exclusion

  • History of diabetes mellitus
  • History of venous insufficiency or peripheral arterial disease
  • Chronic steroid use within the last year
  • History of HIV or chemotherapy use within the last year
  • Smoking history exceeding 10 pack-years or current smoker
  • History of stroke or deep venous thrombosis
  • Active infection or allergy to adhesives
  • Wounds with visible bone, tendon, ligament, or nerve

NCT07285044

Cancer CARE (Connected Access and Remote Expertise) Beyond Walls - Pilot, Phase 2 Clinical Trial to Evaluate Administration of Cancer-Directed Therapy in the Patient's Homes Versus in Clinic in the Florida Panhandle and Surrounding Areas

Organization/Sponsor: Mayo Clinic


Example patient: A 62-year-old woman with metastatic melanoma receiving pembrolizumab infusions, ECOG status 1, living independently in Pensacola with home Wi-Fi, tolerating treatment well for 8 weeks and planning to continue therapy.

Phase 2

Interventions

  • Behavioral: Questionnaire Administration
    Summary: Data collection tool requiring participants to complete questionnaires to assess outcomes and experiences during home-based cancer therapy administration (NCI Thesaurus).
  • Procedure: Cancer Therapeutic Procedure
    Summary: Standard-of-care cancer treatment interventions including immunotherapies, targeted therapies, and supportive medications administered in patient homes versus clinic settings (NCI Thesaurus).

Key Inclusion

  • Histologically confirmed malignancy receiving eligible treatment regimen
  • Age 18 years or older
  • ECOG performance status 0-3
  • Adequate tolerability of standard-of-care treatment
  • Resides in Florida Panhandle and surrounding service area
  • Home has Wi-Fi connection or can be provided mobile device
  • Plans to continue eligible treatment for at least 12 weeks
  • Social stability appropriate for home-based program

Key Exclusion

  • Co-morbid illnesses making patient inappropriate for study entry
  • Receiving investigational agent for primary neoplasm treatment
  • Requires continuous 24/7 assistance without available caregiver support
  • Current inpatient hospitalization excluding Advanced Care at Home

NCT07068074

A Randomized Phase III Study of Management of Treatment Naive Primary Melanoma in Elderly Patients

Organization/Sponsor: Eastern Cooperative Oncology Group


Example patient: A 78-year-old Spanish-speaking patient with ECOG performance status 1, newly diagnosed cutaneous melanoma on the arm, no active infections, NYHA class 2A cardiac function, and no prior surgeries in the axillary region.

Phase III

Interventions

  • Procedure: Sentinel Lymph Node and Wide Local Excision
    Summary: A surgical procedure in which normal tissue is cut out in addition to the lesion or tumor, combined with sentinel lymph node biopsy for melanoma staging (NCI Thesaurus).
  • Procedure: Wide local Excision
    Summary: A surgical procedure in which normal tissue is cut out in addition to the lesion or tumor for definitive melanoma treatment (NCI Thesaurus).

Key Inclusion

  • Age ≥ 75 years
  • ECOG Performance Status 0-2
  • Newly diagnosed primary cutaneous melanoma
  • Wide local excision and sentinel lymph node biopsy indicated
  • Eligible for surgery
  • English or Spanish speaking (French in Canada)

Key Exclusion

  • Active infection precluding enrollment
  • Contraindication to sentinel lymph node biopsy
  • Prior surgery in draining basin making SLN biopsy difficult
  • Prior lymphadenectomy
  • Uncontrolled medical condition precluding surgery
  • New York Heart Association cardiac function class worse than 2B

NCT07225036

PRIME-LRT: PRomoting IMmunotherapy Efficacy With Low-Dose Liver RT Genomic-based

Organization/Sponsor: University of Cincinnati


Example patient: A 62-year-old man with biopsy-proven metastatic melanoma and liver metastases, ECOG status 1, starting pembrolizumab immunotherapy with insurance coverage for radiation.

Phase N/A

Interventions

  • Radiation: LD-LRT
    Summary: Low-dose liver radiation therapy studied to enhance immunotherapy efficacy by targeting liver metastases in NSCLC and melanoma patients receiving PD-1/PD-L1 checkpoint inhibitors (Source: Web Search).

Key Inclusion

  • Age ≥18 years
  • ECOG performance status ≤2
  • Biopsy proven NSCLC or Melanoma
  • Radiographic evidence of liver metastases
  • Planning active treatment with PD-L1 or PD-1 checkpoint immunotherapy
  • Adequate organ and marrow function for immunotherapy
  • Insurance authorization for radiotherapy
  • Adequate contraception for women of child-bearing potential and men

Key Exclusion

  • Adjuvant immunotherapy within 6 months of enrollment
  • NSCLC with EGFR, ALK, ROS1, or RET driver mutations (cohort 1)
  • Uncontrolled intercurrent illness
  • Prior or concurrent malignancy interfering with safety assessment
  • Pregnant women

NCT06365619

Phase II Study of Neoadjuvant Ipilimumab/Nivolumab for Patients With Recurrent, High Risk, Resectable Melanoma

Organization/Sponsor: University of Utah


Example patient: A 52-year-old with ECOG status 1 and Stage IV melanoma that recurred 2 months after completing adjuvant pembrolizumab, now with resectable lung metastases confirmed by biopsy, adequate organ function, and no brain metastases.

Phase II

Interventions

  • Biological: Nivolumab
    Summary: Nivolumab is a fully human IgG4 monoclonal antibody that blocks PD-1, preventing its interaction with PD-L1 and PD-L2, thereby activating T-cells and enhancing immune responses against tumors. FDA-approved for multiple advanced cancers including melanoma, it is used as monotherapy or combined with other immunotherapies. Source: FDA label and NCI Thesaurus.
  • Biological: Ipilimumab
    Summary: Ipilimumab is a recombinant human IgG1 monoclonal antibody that blocks CTLA-4 on T-cells, preventing downregulation of T-cell activation and enhancing cytotoxic immune responses against cancer. FDA-approved for melanoma and other advanced cancers, often combined with nivolumab. Source: FDA label and NCI Thesaurus.

Key Inclusion

  • Age ≥18 years
  • Histologically confirmed Stage IIIB-D or Stage IV recurrent metastatic melanoma that is resectable or borderline resectable
  • Recurrent disease confirmed by biopsy while receiving or within 3 months of completion of adjuvant anti-PD1 therapy
  • ECOG Performance Status ≤1
  • Adequate hematologic function (ANC ≥1500/mm3, platelets ≥100,000/mm3, hemoglobin ≥10 g/dL)
  • Adequate hepatic function (bilirubin ≤1.5x ULN, AST/ALT ≤3x ULN or ≤5x ULN with liver metastases)
  • Adequate renal function (creatinine clearance ≥50 mL/min)
  • Recovery to baseline or ≤Grade 1 from prior treatment toxicities

Key Exclusion

  • Receiving investigational agents currently or within 28 days
  • Prior systemic anti-cancer therapy ≤14 days or within five half-lives
  • Known brain metastases or cranial epidural disease
  • Active secondary malignancy expected to interfere with evaluation
  • Systemic steroid therapy >10mg prednisone/day or immunosuppressive therapy within 7 days
  • Major surgery within 4 weeks or not fully recovered
  • Cardiovascular disorders including NYHA Class III/IV heart failure, MI/stroke within 3 months, QTcF >500 ms
  • HIV with detectable viral load, active hepatitis B or C, or active tuberculosis

NCT07317505

A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of JMT108 Injection in Participants With Advanced Malignant Tumors

Organization/Sponsor: Conjupro Biotherapeutics, Inc.


Example patient: A 62-year-old with metastatic melanoma refractory to checkpoint inhibitors and targeted therapy, ECOG 1, with measurable lung lesions and no brain metastases.

Phase 1

Interventions

  • Drug: JMT108
    Summary: JMT108 is an investigational drug targeting advanced melanoma and other solid tumors with undisclosed mechanism of action, being studied for safety and anti-tumor activity (Source: Web Search).

Key Inclusion

  • Age ≥18 years
  • Histologically or cytologically confirmed locally advanced or metastatic solid tumors
  • Unresponsive or intolerant to all standard of care or no standard of care available
  • At least one evaluable tumor lesion per RECIST v1.1
  • ECOG performance status ≤2
  • Expected survival ≥3 months

Key Exclusion

  • Active central nervous system metastases or leptomeningeal metastases
  • Adverse events from prior therapy not recovered to Grade ≤1 or baseline
  • Investigational drugs within 4 weeks prior to C1D1
  • Chemotherapy, radiotherapy, biological, endocrine, targeted, or immunotherapy within 4 weeks prior to first dose
  • Nitrosoureas or mitomycin C within 6 weeks prior to first dose
  • Oral fluoropyrimidines or small-molecule targeted drugs within 2 weeks or 5 half-lives
  • Herbal medicine with anti-tumor indications within 2 weeks prior to first dose

NCT07287917

A Phase 1b/2 Trial Investigating the Safety and Efficacy of Oral AMXT 1501 and Oral DFMO in Combination With Standard of Care in Patients With Advanced Solid Tumors Who Progressed After Prior Therapies Genomic-based

Organization/Sponsor: Aminex Therapeutics, Inc.


Example patient: A 52-year-old postmenopausal woman with metastatic ER+/HER2- breast cancer harboring PIK3CA mutation, ECOG 1, who progressed on two prior endocrine-based regimens and is eligible for capivasertib therapy.

Phase 1b, Phase 2

Interventions

  • Biologic: Pembrolizumab
    Summary: Humanized monoclonal antibody blocking PD-1 receptor to enhance T-cell-mediated immune responses against tumors; FDA-approved for melanoma and multiple solid tumors; carries risk of immune-related adverse events (FDA label, NCI Thesaurus).
  • Drug: Capivasertib
    Summary: Oral AKT kinase inhibitor blocking PI3K/AKT/mTOR signaling to inhibit tumor cell growth; FDA-approved with fulvestrant for HR+/HER2- breast cancer with PIK3CA/AKT1/PTEN alterations after endocrine therapy progression (FDA label, NCI Thesaurus).
  • Drug: Fulvestrant
    Summary: Estrogen receptor antagonist administered intramuscularly; FDA-approved for HR+/HER2- advanced breast cancer as monotherapy or with CDK4/6 inhibitors; blocks estrogen signaling in estrogen-dependent tumors (FDA label, NCI Thesaurus).
  • Drug: DFMO
    Summary: Difluoromethylated ornithine compound that irreversibly inhibits ornithine decarboxylase, blocking polyamine biosynthesis required for tumor cell proliferation and inducing apoptosis (NCI Thesaurus).
  • Drug: AMXT 1501 Dicaprate
    Summary: Oral polyamine transport inhibitor blocking polyamine uptake into tumor microenvironment; decreases intratumoral polyamine concentrations to inhibit proliferation, induce apoptosis, and reverse polyamine-mediated immune suppression (NCI Thesaurus).

Key Inclusion

  • ≥18 years old with unresectable/metastatic solid tumors
  • ER+ HER2- breast cancer with PIK3CA/AKT1/PTEN alterations after ≥2 endocrine regimens
  • Unresectable metastatic melanoma progressed on immune checkpoint inhibitor
  • BRAF-mutant melanoma progressed on BRAF/MEK inhibitor
  • Measurable disease by RECIST 1.1
  • ECOG performance status 0-1
  • Adequate organ function (ANC ≥1.5×10⁹/L, platelets ≥100×10⁹/L, hemoglobin ≥9 g/dL)
  • Life expectancy ≥12 weeks

Key Exclusion

  • Active CNS metastases or carcinomatous meningitis
  • Active autoimmune disease requiring systemic treatment in past 2 years
  • Cardiovascular disease (uncontrolled hypertension, MI, heart failure, EF <50%, arrhythmias)
  • QTcF >450ms or significant ECG abnormalities
  • Active bacterial, viral, or fungal infections requiring systemic therapy
  • Prior adriamycin use
  • Active hepatitis A, B, or C
  • Unresolved toxicity >Grade 1 from prior anticancer therapy