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About Bolder Science

Our mission is to provide healthcare professionals with unbiased clinical research information, easily.

Currently, you can access the following clinical trials being conducted worldwide:

354,475 studies
in
216 countries
Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 12/03/2020.
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Clinical Trials of Interest

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Drug Interventions

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 12/03/2020.
Displaying: 11 trials in your specialties ()
View trials across your selected specialties

A Study to Evaluate Immune Biomarker Modulation in Response to VTX-2337 in Combination With an Anti- PD-1 Inhibitor in Head and Neck Cancer

  • Status
    Recruiting
  • Phase
    Phase 1
  • Condition
    Carcinoma, Squamous Cell
View Full Trial
INTERVENTION

Drug: VTX-2337, Drug: Nivolumab

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

University of Alabama at Birmingham, Birmingham, Alabama, United States

Brief Summary

This is an open label, Phase 1b pre-operative window of opportunity biomarker trial to analyze the combination of intravenous (IV) anti-PD-1 inhibitor, nivolumab, given along with toll-like receptor 8 (TLR 8) agonist motolimod delivered either subcutaneously (SC) or by intratumoral injection (IT) in subjects with squamous cell carcinoma of the head and neck (SCCHN). Subjects with previously untreated, resectable SCCHN, will be recruited onto this trial and will initially undergo pre-treatment diagnostic imaging and biological sample collection. These subjects will undergo pre-operative study treatment for a 3 to 4-week period prior to a scheduled surgical resection.

Intratumoral Microdosing of Motolimod in HNSCC

  • Status
    Not yet recruiting
  • Phase
    Early Phase 1
  • Condition
    HNSCC
View Full Trial
INTERVENTION

Drug: Motolimod, Biological: Nivolumab, Combination Product: Motolimod + Nivolumab

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

Brief Summary

This is a multi-center, single arm, open-label, multi-agent, localized pharmacodynamic biomarker Phase 0 trial designed to study the biological effects within the tumor microenvironment of motolimod and motolimod combined with nivolumab when administered intratumorally in microdose quantities via the CIVO device in patients with head and neck squamous cell carcinoma (HNSCC). CIVO stands for comparative in vivo oncology.

Phase 1/2 Study of Motolimod, Doxorubicin, and Durvalumab in Recurrent, Platinum-Resistant Ovarian Cancer

  • Status
    Active, not recruiting
  • Phase
    Phase 1 Phase 2
  • Condition
    Ovarian Cancer
View Full Trial
INTERVENTION

Drug: Durvalumab, Drug: Pegylated Liposomal Doxorubicin, Drug: Motolimod

Eligibility
  • Ages:
  • Sexes: Female
  • Accepts Healthy Volunteers:
Locations

Research Facitlity, Phoenix, Arizona, United States

Brief Summary

This is an ongoing Phase 1/2, open-label, multicenter, non-randomized study of MEDI4736 (durvalumab) in subjects with recurrent, platinum-resistant ovarian cancer who are scheduled to receive pegylated liposomal doxorubicin (PLD).The primary objective of Phase 1 is to determine the maximum tolerated dose (MTD) and safety profile, with a secondary objective to evaluate the clinical efficacy as measured by progression-free survival (PFS) rate at 6 months (PFS-6). The primary objective of Phase 2 is the evaluation of clinical efficacy as measured by PFS-6. For both phases, secondary objectives include evaluation of clinical efficacy as measured by overall response rate, PFS, and overall survival (OS), safety and tolerability, and immunological responses.

TLR8 Agonist VTX-2337 and Cetuximab in Treating Patients With Locally Advanced, Recurrent, or Metastatic Squamous Cell Cancer of Head and Neck

  • Status
    Completed
  • Phase
    Phase 1
  • Condition
    Tongue Cancer, Metastatic Squamous Neck Cancer With Occult Primar...
View Full Trial
INTERVENTION

Other: pharmacogenomic studies, Other: laboratory biomarker analysis, Drug: TLR8 agonist VTX-2337, Biological: cetuximab

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium, Seattle, Washington, United States

Brief Summary

This phase I trial studies the side effects and best dose of TLR8 Agonist VTX-2337 when given together with cetuximab in treating patients with locally advanced, recurrent, or metastatic squamous cell cancer of the head and neck (SCCHN). Biological therapies, such as TLR8 Agonist VTX-2337 may stimulate the immune system in different ways and stop tumor cells from growing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving TLR8 Agonist VTX-2337 together with cetuximab may kill more tumor cells.

Chemotherapy Plus Cetuximab in Combination With VTX-2337 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

  • Status
    Completed
  • Phase
    Phase 2
  • Condition
    Carcinoma, Squamous Cell of Head and Neck
View Full Trial
INTERVENTION

Drug: VTX-2337, Drug: Carboplatin, Drug: Cisplatin, Drug: 5-fluorouracil, Drug: Placebo

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States

Brief Summary

The purpose of this study is to compare the progression-free survival of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) treated with VTX-2337 + cisplatin or carboplatin + 5-FU + cetuximab versus patients treated with cisplatin or carboplatin + 5-FU + cetuximab alone (standard-of-care; SOC). Safety and overall survival will also be evaluated.

Safety and Pharmacologic Study of VTX-2337 in Patients With Advanced Cancer

  • Status
    Completed
  • Phase
    Phase 1
  • Condition
    Advanced Solid Tumors, Lymphoma
View Full Trial
INTERVENTION

Drug: VTX-2337

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

Mayo Clinic, Scottsdale, Arizona, United States

Brief Summary

This is a multi-center, Phase I study of a new investigational drug, VTX-2337, that may stimulate the immune system to help fight cancer. The purpose of the study is to assess the safety of the investigational drug and to identify the highest dose that is well-tolerated. The pharmacology of VTX-2337 will also be evaluated.

VTX-2337 and Pegylated Liposomal Doxorubicin (PLD) in Patients With Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer

  • Status
    Completed
  • Phase
    Phase 2
  • Condition
    Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Periton...
View Full Trial
INTERVENTION

Drug: pegylated liposomal doxorubicin (PLD), Drug: VTX-2337, Drug: Placebo

Eligibility
  • Ages:
  • Sexes: Female
  • Accepts Healthy Volunteers:
Locations

St. Joseph's Hospital and Medical Center, Phoenix, Arizona, United States

Brief Summary

The purpose of this study is to compare the overall survival of patients treated with VTX-2337 + pegylated liposomal doxorubicin (PLD) versus those treated with PLD alone in women with recurrent or persistent, epithelial ovarian, fallopian tube or primary peritoneal cancer. VTX-2337, a small molecule agonist of Toll-like Receptor 8 (TLR8), activates multiple components of the innate immune system and is being developed as a novel therapeutic agent for use in oncology. Experimental data obtained in an animal model of ovarian cancer supports the combination of VTX-2337 with PLD. In this model, the combination of VTX-2337 and PLD resulted in a significant reduction in tumor growth compared to either agent alone and an increase in the number of T lymphocytes infiltrating the tumor. The combination of PLD and VTX-2337 has been tested in a small number of women with ovarian cancer in a Phase 1b study and appears to be generally well-tolerated.

TLR8 Agonist VTX-2337 and Pegylated Liposomal Doxorubicin Hydrochloride or Paclitaxel in Treating Patients With Recurrent or Persistent Ovarian Epithelial, Fallopian Tube, or Peritoneal Cavity Cancer

  • Status
    Completed
  • Phase
    Phase 1
  • Condition
    Malignant Ovarian Mixed Epithelial Tumor, Ovarian Brenner Tumor, ...
View Full Trial
INTERVENTION

Drug: TLR8 Agonist VTX-2337, Other: Diagnostic Laboratory Biomarker Analysis, Other: Pharmacological Study, Drug: Pegylated Liposomal Doxorubicin Hydrochloride, Drug: Paclitaxel

Eligibility
  • Ages:
  • Sexes: Female
  • Accepts Healthy Volunteers:
Locations

Gynecologic Oncology Group of Arizona, Phoenix, Arizona, United States

Brief Summary

This phase I trial is studying the side effects and best dose of TLR8 agonist VTX-2337 and pegylated liposomal doxorubicin hydrochloride in treating patients with recurrent or persistent ovarian epithelial, fallopian tube, or peritoneal cavity cancer. Biological therapies, such as TLR8 agonist VTX-2337, may stimulate the immune system in different ways and stop tumor cells from growing. Drugs used in chemotherapy, such as pegylated liposomal doxorubicin hydrochloride and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving TLR8 agonist VTX-2337 together with pegylated liposomal doxorubicin hydrochloride or paclitaxel may kill more tumor cells.

A Phase Ib Study of Neoadjuvant of Cetuximab Plus Motolimod and Cetuximab Plus Motolimod Plus Nivolumab

  • Status
    Other
  • Phase
    Phase 1
  • Condition
    Squamous Cell Carcinoma of the Head and Neck
View Full Trial
INTERVENTION

Drug: Motolimod, Drug: Cetuximab, Drug: Nivolumab

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States

Brief Summary

Protocol VRXP-A106 will enroll patients with Stage II-IVA head and neck cancer patients who will be treated with surgical resection. Cetuximab and motolimod (Cohort 1); and cetuximab, motolimod, and nivolumab (Cohort 2) will be administered for a 3-4 week period before surgery. The primary objective of the study is to determine the extent to which the administration of neoadjuvant motolimod plus cetuximab and motolimod plus cetuximab and nivolumab modulates immune biomarkers (NK, mDC and T cell activation as well as tumor infiltration and serum cytokines) in peripheral blood and head and neck cancer tumors. An exploratory objective of the study is to assess whether modulation of biomarkers as described above can predict anti-tumor response.

VTX-2337 in Combination With Radiotherapy in Patients Low-Grade B-cell Lymphomas

  • Status
    Other
  • Phase
    Phase 1 Phase 2
  • Condition
    Low Grade B Cell Lymphoma
View Full Trial
INTERVENTION

Drug: VTX-2337 plus radiotherapy

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

Stanford Cancer Center, Stanford, California, United States

Brief Summary

This study is to determine the safety and effectiveness of VTX-2337 (an investigational drug that stimulates the immune system) in combination with radiation therapy in treating patients with low-grade B-cell lymphoma. Patients will receive 2 low doses of radiotherapy, and 9 intratumoral injections of VTX-2337 over the course of 3 months.