This website is for US healthcare professionals

close-icon

Log In to Bolder Science

or

Don't have an account? Sign Up

close-icon

Please enter your email address.

You will receive a link to create a new password via email.

Log In

close-icon

Create an Account

or
  • 8 characters minimum
  • First character may not be a number
  • Last character may not be a number
close-icon

Welcome and thank you for creating an account!

At Bolder Science, we want your clinical trial search experience to be the best it can be. Complete the following prompts to easily find the trials you are interested in and see trials recruiting near you. You can adjust these selections in your dashboard after creating your account.

Condition Categories

Condition categories are pulled directly from ClinicalTrials.gov. Choose 1 or more condition categories that you are interested in:

Clinical Trials of Interest

When I’m looking for information on clinical trials, I usually am interested in...

Set a default location

Back
Filter 11 trials Clear all
Filter by:

Intratumoral Microdosing of Motolimod in HNSCC

  • Status Recruiting
    Recruiting
  • Condition HNSCC
    HNSCC
  • Phase Early Phase 1
    Early Phase 1
INTERVENTION

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

Eligibility
  • Ages: 18 Years and older (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
INTERVENTION

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

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

University of California, San Francisco, San Francisco, California, United States

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.

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
    Recruiting
  • Condition Carcinoma, Squamous Cell
    Carcinoma, Squamous Cell
  • Phase Phase 1
    Phase 1
INTERVENTION

Drug: VTX-2337, Drug: Nivolumab

Eligibility
  • Ages: 18 Years and older (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
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.

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

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

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

Eligibility
  • Ages: 18 Years and older (Adult, Older Adult)
  • Sexes: Female
  • Accepts Healthy Volunteers: No
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
    Completed
  • Condition Stage IVA Verrucous Carcinoma of the Larynx, Stage IVA Verrucous ...
    Stage IVA Verrucous Carcinoma of the Larynx, Stage IVA Verrucous ...
  • Phase Phase 1
    Phase 1
INTERVENTION

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

Eligibility
  • Ages: 18 Years and older (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
INTERVENTION

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

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
    Completed
  • Condition Carcinoma, Squamous Cell of Head and Neck
    Carcinoma, Squamous Cell of Head and Neck
  • Phase Phase 2
    Phase 2
INTERVENTION

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

Eligibility
  • Ages: 18 Years and older (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
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
    Completed
  • Condition Advanced Solid Tumors, Lymphoma
    Advanced Solid Tumors, Lymphoma
  • Phase Phase 1
    Phase 1
INTERVENTION

Drug: VTX-2337

Eligibility
  • Ages: 18 Years and older (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
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
    Completed
  • Condition Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Periton...
    Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Periton...
  • Phase Phase 2
    Phase 2
INTERVENTION

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

Eligibility
  • Ages: 18 Years and older (Adult, Older Adult)
  • Sexes: Female
  • Accepts Healthy Volunteers: No
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
    Completed
  • Condition Ovarian Mucinous Cystadenocarcinoma, Recurrent Fallopian Tube Car...
    Ovarian Mucinous Cystadenocarcinoma, Recurrent Fallopian Tube Car...
  • Phase Phase 1
    Phase 1
INTERVENTION

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

Eligibility
  • Ages: 18 Years and older (Adult, Older Adult)
  • Sexes: Female
  • Accepts Healthy Volunteers: No
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 Terminated
    Terminated
  • Condition Squamous Cell Carcinoma of the Head and Neck
    Squamous Cell Carcinoma of the Head and Neck
  • Phase Phase 1
    Phase 1
INTERVENTION

Drug: Motolimod, Drug: Cetuximab, Drug: Nivolumab

Eligibility
  • Ages: 18 Years and older (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
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.

TLR8 Agonist VTX-2337 and Cyclophosphamide in Treating Patients With Metastatic, Persistent, Recurrent, or Progressive Solid Tumors

  • Status Terminated (permanently closed per sponsor's request)
    Terminated (permanently closed per sponsor's request)
  • Condition Recurrent Breast Carcinoma, Colorectal Adenocarcinoma, Metastatic...
    Recurrent Breast Carcinoma, Colorectal Adenocarcinoma, Metastatic...
  • Phase Phase 1
    Phase 1
INTERVENTION

Drug: Cyclophosphamide, Other: Laboratory Biomarker Analysis, Biological: Pegfilgrastim, Other: Pharmacological Study, Drug: TLR8 Agonist VTX-2337

Eligibility
  • Ages: 18 Years and older (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
INTERVENTION

Drug: Cyclophosphamide, Other: Laboratory Biomarker Analysis, Biological: Pegfilgrastim, Other: Pharmacological Study, Drug: TLR8 Agonist VTX-2337

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

Mayo Clinic in Arizona, Scottsdale, Arizona, United States

Brief Summary

This phase Ib trial studies the best way of TLR8 Agonist VTX-2337 and cyclophosphamide in treating patients with a solid tumor that has spread from the primary site (place where it started) to other places in the body (metastatic), progressed for a long time (persistent), come back (recurrent), or is growing, spreading, or getting worse (progressed). TLR8 Agonist VTX-2337 may stimulate the immune system in different ways and stop tumor cells from growing. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving TLR8 Agonist VTX-2337 together with cyclophosphamide may be a better treatment for solid tumors.