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Monthly Update Report for Trials Started in February 2026


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1: Summary data from new trials identified for Melanoma.


Overview

Number of Trials: 6

These six trials investigate immunotherapy strategies for advanced solid tumors, with a strong focus on melanoma. Four trials specifically target melanoma patients, while two include multiple tumor types. Common themes include checkpoint inhibitor therapy (anti-PD-1, anti-CTLA-4), novel vaccine approaches, and strategies to overcome immunotherapy resistance. Trials explore dendritic cell vaccines, personalized RNA vaccines, combination immunotherapies, and timing optimization of checkpoint inhibitors across various solid tumors including melanoma, sarcoma, lung, renal, and hepatobiliary cancers.

Common Criteria Across Trials

Common Inclusion

  • Age 18 years or older
  • ECOG performance status 0-2
  • Adequate organ function (liver, kidney, bone marrow)
  • Measurable disease per RECIST 1.1
  • Histologically or cytologically confirmed diagnosis
  • Life expectancy adequate for study participation
  • Negative pregnancy test for females of childbearing potential
  • Effective contraception required during study

Common Exclusion

  • Active brain metastases or symptomatic CNS disease
  • Active autoimmune disease requiring immunosuppression
  • Systemic corticosteroids exceeding 10mg prednisone daily equivalent
  • Active uncontrolled infection
  • HIV with detectable viral load or low CD4 count
  • Active hepatitis B or untreated hepatitis C
  • Pregnancy or breastfeeding
  • Prior organ transplant
  • Severe cardiac disease or recent cardiovascular events
  • Other active malignancies

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


NCT07288112

Clinical Study of DOC1021 Dendritic Cell Immunotherapy for Refractory Melanoma

Organization/Sponsor: Diakonos Oncology Corporation


Example patient: A 62-year-old male with ECOG 1, metastatic melanoma refractory to pembrolizumab with multiple accessible subcutaneous lesions and stable treated brain metastases, adequate organ function, and no active autoimmune disease.

Phase N/A

Interventions

  • Biological: DOC1021
    Summary: DOC1021 is a dendritic cell vaccine targeting melanoma that stimulates a TH1 immune response, tested in refractory and newly diagnosed melanoma patients (Summary of Web Search).
  • Drug: pIFN (peginterferon alfa-2a)
    Summary: Peginterferon alfa-2a is a PEGylated interferon alpha-2a that induces innate immune responses with antiviral, antiproliferative, and immune-modulating effects; PEG conjugation extends therapeutic duration (FDA label, NCI Thesaurus).
  • Procedure: Tumor resection
    Summary: Surgical removal of cancerous tissue to obtain tumor material for vaccine generation and prevent recurrence, often combined with other therapies (NCI Thesaurus, Web Search).

Key Inclusion

  • Age 18 years or older
  • Unresectable or metastatic melanoma progressed after ≥1 prior systemic therapy including anti-PD-1
  • Refractory to anti-PD-1 (primary or secondary resistance)
  • Lesions available for biopsy yielding at least 50 mg tumor tissue
  • At least 1 measurable target lesion by RECIST v1.1
  • Stable brain metastases after prior treatment allowed
  • ECOG Performance Status 0 or 1
  • Adequate kidney, liver, bone marrow, and immune function

Key Exclusion

  • Pregnant or breastfeeding
  • Active HIV or hepatitis infection (controlled HIV with undetectable viral load allowed)
  • Severe cardiac disease or systemic autoimmune disorders requiring immunosuppression
  • Autoimmune disorders requiring DMARDs, TNF inhibitors, or JAK inhibitors
  • Residual immune-related toxicities from prior immunotherapy >Grade 1
  • Autoimmune hepatitis or untreated viral hepatitis
  • Treatment with investigational drug within last 30 days

NCT07224425

A First-in-human, Phase I, Open-label, Non-randomized, Multicentre Dose Escalation and Expansion Trial of BI 3810944 in Patients With Solid Tumours and Melanoma Genomic-based

Organization/Sponsor: Boehringer Ingelheim


Example patient: A 52-year-old with BRAF-mutant metastatic melanoma, ECOG 1, who progressed after two lines of therapy including immunotherapy, with measurable lung metastases and no active brain lesions.

Phase I

Interventions

  • Drug: BI 3810944
    Summary: BI 3810944 is an investigational drug with undisclosed targets and mechanisms being studied for safety and efficacy in advanced melanoma and solid tumours (source: Web Search).

Key Inclusion

  • Part A: solid tumour failed conventional treatment or no therapy of proven efficacy exists
  • Part B: melanoma progressed on or intolerant to standard therapies, BRAF mutation status known
  • Maximum 3 previous lines of treatment for Part B
  • ECOG performance status 0 or 1
  • At least one measurable lesion outside CNS per RECIST v1.1
  • Age ≥18 years
  • Adequate organ function
  • Life expectancy ≥3 months

Key Exclusion

  • Active primary CNS malignancy or active untreated CNS metastases
  • Immunodeficiency or immunosuppressive therapy exceeding prednisone 10 mg daily within 7 days
  • Anticancer therapy within 28 days or 5 half-lives prior to first dose
  • Extensive field radiotherapy including whole brain irradiation within 2 weeks
  • Prior organ transplant or hematopoietic stem-cell transplant
  • Anticoagulant treatment that cannot be safely interrupted
  • Pregnant, breastfeeding, or planning pregnancy during trial or within 4 months after last dose
  • Prior toxicities not resolved to Grade ≤1 except alopecia, peripheral neuropathy, amenorrhea

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 1 status and Stage IV resectable metastatic melanoma that recurred 2 months after completing adjuvant pembrolizumab, with 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 receptor, preventing its interaction with PD-L1 and PD-L2, thereby activating T-cells and enhancing immune response against cancer cells (FDA label, NCI Thesaurus).
  • Biological: Ipilimumab
    Summary: Ipilimumab is a monoclonal antibody that targets CTLA-4 to enhance immune response against melanoma, improving survival rates in clinical trials (Web Search Summary).

Key Inclusion

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

Key Exclusion

  • Investigational agents within 28 days
  • Prior systemic anti-cancer therapy ≤14 days or within five half-lives
  • Prior radiotherapy within 45 days
  • Major surgery within 4 weeks
  • Active infection requiring systemic antibiotics
  • Systemic steroids >10mg prednisone equivalent within 7 days
  • Known brain metastases or cranial epidural disease
  • Significant cardiovascular disease (NYHA Class III/IV CHF, MI/stroke within 3 months, QTcF >500ms, LVEF <55%)

NCT07102212

Randomized Clinical Trial of a Telemedicine-mHealth Symptom Cluster Intervention for Advanced Cancer Patients: Increasing Access in Rural Areas

Organization/Sponsor: Ohio State University Comprehensive Cancer Center


Example patient: A 62-year-old English-speaking woman with stage IV melanoma experiencing moderate insomnia and severe fatigue who uses email regularly and has an ECOG performance status of 1.

Phase N/A

Interventions

  • Behavioral: mHealth Intervention
    Summary: Mobile technology-based intervention using telemedicine to manage symptom clusters including insomnia, depression, anxiety, and fatigue in advanced cancer patients, offering personalized support and tracking (Web Search, NCI Thesaurus).

Key Inclusion

  • Advanced cancer (stage IIIb/c or IV lung, stage IV breast, stage IV prostate, advanced multiple myeloma, stage IIIb/IV melanoma)
  • Age 18 years or older
  • Able to read and write in English
  • Use internet and email
  • Meet clinical cut-offs on at least two symptoms: insomnia (ISI ≥8), depression (PHQ-2 ≥3), anxiety (GAD-2 ≥2), or fatigue (FSI ≥3)

Key Exclusion

  • Night-shift work
  • Untreated bipolar disorder
  • Substance use disorder
  • Cognitive impairment
  • ECOG performance status 3 or greater (in bed 50% or more of day)
  • Less than 6 months predicted survival

NCT05264974

Novel RNA-lipid Particle (RNA-LP) Vaccine for Anti-PD-1 Antibody Therapy Sensitization Genomic-based

Organization/Sponsor: University of Florida


Example patient: A 52-year-old with BRAF wildtype stage IV acral melanoma who progressed 4 months after completing adjuvant pembrolizumab, with ECOG 1, accessible tumor for biopsy, and no brain metastases.

Phase N/A

Interventions

  • Biological: Autologous total tumor mRNA loaded DOTAP liposome vaccine
    Summary: An mRNA-based personalized cancer vaccine using total tumor RNA from autologous tumor cells formulated in DOTAP lipid nanoparticles. The vaccine induces CTL and memory T-cell responses against tumor antigens presented by APCs via MHC molecules. Source: NCI Thesaurus.

Key Inclusion

  • Adults ≥18 years old with ECOG performance ≤2
  • Disease amenable to surgical sampling for RNA extraction
  • Melanoma with progression on or within 6 months after adjuvant aPD1 therapy for stage IIB-IV
  • Primary or secondary immunotherapy resistance with checkpoint inhibitors
  • BRAF wildtype or contraindication/progression/decline of BRAF/MEK therapy
  • Soft tissue sarcoma with unresectable stage II, stage III, or stage IV disease
  • Adequate organ function and laboratory values within specified ranges
  • Negative pregnancy test and contraception use for women of childbearing potential

Key Exclusion

  • Active second malignancy or symptomatic brain/leptomeningeal metastases
  • History of severe immune-mediated adverse reactions to aPD1 therapy
  • Corticosteroids >10mg prednisone daily or immunosuppressive medications within 14 days
  • Active autoimmune disease posing significant risk or requiring systemic immunosuppression
  • Post-splenectomy, asplenic, or moderate to severe splenomegaly
  • Known HIV with CD4+ ≤350 cells/ul or positive viral load
  • Active hepatitis B or untreated hepatitis C
  • Sarcoma patients who received dual checkpoint inhibition

NCT07405086

Knight Cancer Institute Study of Histology-Agnostic Immunotherapy With Focus on Timing: - Knight SHIFT - A Prospective, Multi-Histology Pragmatic Study Genomic-based

Organization/Sponsor: OHSU Knight Cancer Institute


Example patient: A 62-year-old patient with driver-negative metastatic NSCLC and measurable lung lesions, no prior immunotherapy, and no active autoimmune disease, planned for pembrolizumab treatment.

Phase N/A

Interventions

  • Drug: Immune Checkpoint Inhibitor
    Summary: Targets proteins like PD-1, PD-L1, and CTLA-4 to enhance immune response against cancer cells. Used across multiple cancer types to improve treatment outcomes. Source: NCI Thesaurus and Web Search.
  • Procedure: Biospecimen Collection
    Summary: Gathering tissue and fluid samples for research to analyze genetic and molecular features. Supports understanding of cancer mechanisms and development of targeted therapies. Source: NCI Thesaurus and Web Search.

Key Inclusion

  • Aged ≥ 18 years
  • Histologically confirmed advanced/metastatic solid tumor (NSCLC, HNSCC, RCC, BTC, HCC, or Melanoma)
  • Driver-negative NSCLC eligible for immune checkpoint inhibitor
  • Platinum-eligible recurrent or metastatic HNSCC
  • Planned to receive FDA-approved immune checkpoint inhibitor
  • Measurable disease per RECIST 1.1

Key Exclusion

  • Prior ICI-based regimen for cancer treatment
  • Immunosuppressive medication within 28 days before immunotherapy (except intranasal/inhaled corticosteroids or ≤10 mg/day prednisone equivalent)
  • Uncontrolled autoimmune disease requiring immunosuppression
  • Active, uncontrolled CNS metastases