Treatment Trials

408 Clinical Trials for Various Conditions

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RECRUITING
Evaluation of a Novel Point-of-Care Diagnostic Test for Human Papillomavirus (HPV)
Description

To learn if new HPV tests can provide the same results as standard HPV tests. The findings from this study may aid in the development of new HPV tests that require less equipment and are more accessible.

ACTIVE_NOT_RECRUITING
Clinical Decision Support Tools to Increase Human Papillomavirus (HPV) Vaccination in Adolescents in Pharmacies
Description

This clinical trial develops and tests how well a clinical decision support (CDS) tool works to increase human papillomavirus (HPV) vaccination of children between the age of 9-17 (adolescents) in pharmacies. HPV vaccination rate in eligible adolescents remains low even though over 90% of the cancers in adults caused by HPV can be prevented by the HPV vaccine. The National Vaccine Advisory Committee recommends HPV vaccinations to be given in pharmacies to increase access to vaccines, but pharmacy processes and lack of awareness of the service among parents impact the use of local pharmacies for HPV vaccinations. Using a focus group may be an effective method to develop a CDS tool and create a process that may be more convenient for parents to get their adolescent's vaccine at their local pharmacy. A CDS tool may make it easier to obtain HPV vaccines, and as a result increase the adolescent HPV vaccination rate and reduce the incidence of cancer caused by HPV.

ACTIVE_NOT_RECRUITING
Phase 1 Trial in Patients With Human Papillomavirus (HPV)-Associated Cancer
Description

This is an open-label, non-randomized, Phase I, dose escalation/dose expansion study in cohorts of patients with relapsed, resistant, or metastatic HPV-associated cancers. The Expansion Phase will begin in parallel one dose level lower than the highest dose deemed safe in the Dose Escalation in combination with a PD-1 checkpoint blockade.

RECRUITING
A Study Using Human Papillomavirus (HPV) DNA Testing to Detect HPV-Related Oropharyngeal Cancer (OPC)
Description

The researchers think that a blood test (NavDx®) may be able to identify cancer early by looking for circulating DNA from Human Papillomavirus/HPV. Circulating DNA are small pieces of genes that are released into the bloodstream. The purpose of this study is to find out whether using this blood test to test for HPV DNA will help detect HPV-related Oropharyngeal Cancer/OPC.

RECRUITING
E7 TCR-T Cell Immunotherapy for Human Papillomavirus (HPV) Associated Cancers
Description

This is a phase II clinical trial to assess the clinical activity of immunotherapy with E7 TCR-T cells for metastatic HPV-associated cancers. HPV-associated cancers in include cervical, throat, penile, vulvar, vaginal, anal, and other cancers. Participants will receive a conditioning regimen, E7 TCR-T cells, and aldesleukin. Clinical response to treatment will be determined.

RECRUITING
Human Papillomavirus (HPV) Vaccination vs. Placebo for the Treatment of Refractory Cutaneous Warts
Description

This double-blinded clinical trial randomly assigns participants with refractory cutaneous warts to receive either treatment with the human papillomavirus (HPV) vaccine or a placebo to assess the efficacy of HPV vaccination for the treatment of refractory cutaneous warts.

Conditions
RECRUITING
De-escalated Radiation for Human Papillomavirus-Positive Squamous Cell Carcinoma of the Oropharynx
Description

This is a single-arm, observational registry study determining the effects of reduced radiation dose in select patients with human papillomavirus (HPV) positive oropharyngeal cancer.

RECRUITING
A Vaccine (PDS0101) Alone or in Combination With Pembrolizumab for the Treatment of Locally Advanced Human Papillomavirus-Associated Oropharynx Cancer
Description

This phase I/II trial studies how well PDS0101 alone or in combination with pembrolizumab works to shrink tumor in patients with human papillomavirus-associated oropharynx cancer that has spread to nearby tissue or lymph nodes (locally advanced). PDS0101 is a vaccine made from specific peptides that may help the body build an effective immune response to kill tumor cells. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving PDS0101 with or without pembrolizumab may kill more tumor cells in patients with locally advanced human papillomavirus-associated oropharynx cancer before surgery so that it may make the tumor smaller and may reduce the amount of normal tissue that needs to be removed.

RECRUITING
Healthcare Provider Human Papillomavirus Education and Professional Skills Intervention
Description

Healthcare providers (HCP) serving the El Paso U.S.-Mexico Border Region will be recruited to compare educational and professional skills interventions focused on the human papillomavirus (HPV). Our hypothesis is that improving provider knowledge and communication strategies about HPV and its vaccine will reduce hesitancy and increase uptake and completion among the populations they serve.

ACTIVE_NOT_RECRUITING
Adjuvant Treatment Deintensification After Transoral Surgery for Human Papillomavirus-Positive Squamous Cell Carcinoma
Description

Oropharyngeal squamous cell carcinoma (OPSCC), commonly known as throat cancer or tonsil cancer, has seen a dramatic rise in incidence over the last twenty years. There are two types of OPSCC: human papillomavirus-positive (HPV+) and human papillomavirus-negative (HPV-). People with OPSCC, regardless of their type, typically receive standard treatment with a combination of chemotherapy, radiation therapy, and surgery. Due to the intensity of standard treatment, survivors may experience unwanted long-term side effects. The goal of this research study is to see if intensifying (stopping or scaling back) treatment still provides the same, or perhaps even better, results when compared to standard treatment.

TERMINATED
RPTR-168 in Patients With Human Papillomavirus Strain 16 (HPV-16) E6/E7 Positive Tumors and Melanoma
Description

The purpose of this study is to assess the safety and tolerability of escalating doses of RPTR-168 as a monotherapy in patients with HPV-16 E6/E7 positive tumors (HNSCC, cervical) and melanoma.

RECRUITING
The Role of Dentists in Human Papillomavirus Vaccination
Description

This project involves the research into understanding the functioning of co-located/partnering dental practices and federally qualified health centers/community health clinics in North Carolina and how dental health providers may play a role in facilitating HPV vaccination uptake for under-vaccinated populations in these co-located/partnering sites.

Conditions
COMPLETED
Cemiplimab and ISA101b Vaccine in Adult Participants With Recurrent/Metastatic Human Papillomavirus (HPV)16 Cervical Cancer Who Have Experienced Disease Progression After First Line Chemotherapy
Description

The primary objective of the study is to estimate the clinical benefit of cemiplimab + ISA101b after progression on first line chemotherapy, as assessed by objective response rate (ORR). The secondary objectives of the study are: * To characterize the safety profile of cemiplimab + ISA101b * To assess preliminary efficacy of cemiplimab + ISA101b as measured by duration of response (DOR), progression-free survival (PFS), and overall survival (OS)

Conditions
TERMINATED
Self-Sampling for Human Papillomavirus (HPV) at Well Women Appointments
Description

This study seeks to compare the accuracy and acceptability of Human Papillomavirus (HPV) testing self-sampling kit versus standard clinician-sampled HPV testing for cervical cancer screening. The primary outcome of this study is the concordance between screening results on self-sampling kits compared to clinician-collected HPV test and Pap smear results. Secondary endpoints will include acceptability of self-sampling and barriers to cervical cancer screening. These endpoints will be analyzed to try to circumvent barriers to the cervical cancer screening and ascertain whether self-sampling is a viable alternative to clinician sampling.

Conditions
TERMINATED
Self-sampling for Human Papillomavirus (HPV) Among Patients Receiving Colposcopy
Description

This study seeks to compare the accuracy and acceptability of HPV testing self-sampling kit and standard clinician-sampling for HPV testing. The primary outcome of this study is the concordance between screening results on self-sampling kits compared to clinician-collected HPV test, Pap smear results, and colposcopy. Secondary endpoints will include acceptability of self-sampling and barriers to cervical cancer screening. These endpoints will be analyzed to try to circumvent barriers to the cervical cancer screening and ascertain whether self-sampling is a viable alternative.

Conditions
COMPLETED
Anti-PD-L1/TGF-beta Trap (M7824) Alone and in Combination With TriAd Vaccine and N-803 for Resectable Head and Neck Squamous Cell Carcinoma Not Associated With Human Papillomavirus Infection
Description

Background: Some people who get head and neck cancer will need surgery to treat their cancer. Research suggests that immunotherapy drugs may help fight head and neck cancer if given before surgery. In most cases, there is enough time between cancer diagnosis and surgery to test immunotherapy drugs. In this study, researchers are testing the safety and anti-cancer abilities of 3 drugs given before surgery for head and neck cancer. Objective: To learn if giving M7824 alone, or with the TriAd Vaccine (ETBX-011, ETBX-051 \& ETBX-061), or with TriAd vaccine plus Anktiva (N-803) can shrink previously untreated head and neck tumors before surgery or stop the tumors from coming back after all treatment. Eligibility: People age 18 and older who have a head and neck cancer that has not been treated before, and the tumor must be removed with surgery. Design: Participants will be screened in a separate protocol. Participants will have the following tests: * medical history and physical exams * computed tomography or magnetic resonance imaging scans * tumor, mucosa, and skin biopsies * electrocardiograms to monitor heart activity * endoscopies (a tube is inserted through the nose to see the upper airway) * blood and urine tests. All participants will get bintrafusp alfa (M7824) through an intravenous infusion. For this, a small plastic tube is put into an arm vein. Some may also get the TriAd vaccine. It is injected under the skin on the arms or legs. Some may also get N-803. It is injected under the skin on the stomach. Participants will have clinic visits while they are getting treatment and after treatment ends. After treatment ends, participants will have their scheduled surgery. There will be two follow up visits at the National Institutes of Health (NIH) after your surgery. They will be contacted by phone or email every 2 weeks for 3 months. Then they will be contacted every 3 months for 2 years. ...

COMPLETED
De-Escalation Therapy for Human Papillomavirus Negative Disease
Description

This study is looking to see if nivolumab, an immunotherapy drug, given with carboplatin and paclitaxel (2 chemotherapy agents) during induction therapy in advanced stage HPV negative patients can significantly shrink the subject's cancer.

WITHDRAWN
Quality Improvement Strategies to Increase Human Papillomavirus (HPV) Vaccination in Integrated Healthcare Delivery Systems
Description

HPV vaccination coverage is at lower levels than the national goal. This study will evaluate the effectiveness of quality improvement strategies for increasing HPV vaccination coverage among adolescent within the context of large integrated health care delivery systems.

COMPLETED
Increasing Human Papillomavirus (HPV) Vaccine Uptake Via General Health Messaging
Description

Background: Prevention of cervical cancer and genital warts could be achieved by immunization with the prophylactic human papillomavirus (HPV) vaccines commercially available. However, in the U.S. only 38% of females and 14% of males in the recommended age group (9-26 years) receive the complete, three-dose HPV vaccine. Because the HPV vaccine is covered under the Vaccine for Children Program, the underinsured and uninsured have no-cost access. Nonetheless, data from Los Angeles county suggest that HPV vaccination rates among the uninsured and underinsured groups are significantly lower than the national average, likely related to knowledge of the vaccine, transportation, number of doses and concern of side effects. Aim: To evaluate the efficacy of health oriented text messaging to increase HPV vaccine uptake versus standard health messaging (Center for Disease Control and Prevention (CDC) HPV vaccine information flyers). Hypothesis: The investigators hypothesize that receiving general health messaging, including messages regarding the benefits of the HPV vaccine, will increase HPV vaccine uptake. Text messaging will also be more successful in reaching the uninsured and underinsured populations than will traditional flyers/information pamphlets used in clinics. Methods: A cluster randomized trial design will be used to recruit participants from four clinics in Los Angeles County which offer pediatric vaccination to uninsured and underinsured children. The sample will include women aged 18-45 years of age. Two of the sites will be randomized to the text messaging arm and the other clinic will be randomized to the control arm (standard messaging: CDC flyers and pamphlets available for patients at the clinic). Outcome measures will be HPV vaccinations rates at those clinics. Rates will be defined into groups who received 1 dose, 2 doses and 3 doses. Anticipated Results: The investigators expect to find statistically significant higher HPV vaccination rates among children and women in the text messaging study arm compared to the control arm. Implications and Future Studies: This pilot study will give us preliminary data to submit a larger randomized controlled trial to examine the efficacy of text messaging.

COMPLETED
Self-Sampling for Human Papillomavirus (HPV) Testing in African American Women - Mississippi Delta
Description

The purpose of this study is to examine the efficacy and costs of this patient-centered approach ("Choice" between two cervical cancer screening modalities) in adherence to cervical cancer screening as compared to the current standard of care within the public health system in Mississippi (Pap test at the local department -"Pap") among un/under-screened African American women in the Mississippi Delta using a theory-based, culturally relevant intervention implemented by Peer Health Educators (PHEs).

Conditions
TERMINATED
Study of Topical ABI-1968 in Subjects With Precancerous Anal Lesions Resulting From Human Papillomavirus (HPV) Infection
Description

This study evaluates the use of ABI-1968, a topical cream, in the treatment of anal precancerous lesions in adults with and without human immunodeficiency virus (HIV) infection

TERMINATED
Stereotactic Body Radiation Therapy and Durvalumab With or Without Tremelimumab Before Surgery in Treating Participants With Human Papillomavirus Positive Oropharyngeal Squamous Cell Caner
Description

This phase Ib/II trial studies the side effects and how well stereotactic body radiation therapy and durvalumab with or without tremelimumab before surgery work in treating participants with human papillomavirus positive oropharyngeal squamous cell cancer. Stereotactic body radiation therapy is a specialized radiation therapy that sends x-rays directly to the tumor using smaller doses over several days and may cause less damage to normal tissue. Monoclonal antibodies, such as durvalumab and tremelimumab, may interfere with the ability of tumor cells to grow and spread. Giving stereotactic body radiation therapy and durvalumab with or without tremelimumab before surgery may work better in treating participants with oropharyngeal squamous cell cancer.

TERMINATED
Acceptability of Human Papillomavirus (HPV) Self-sampling Tools for Cervical Cancer Prevention
Description

The proposed study aims to increase HPV screening behaviors in Jamaican women by examining the acceptability of HPV Deoxyribonucleic Acid (DNA) self-sampling tools, and to determine the most culturally appropriate and effective message design for promoting such a tool in this context.

Conditions
COMPLETED
Quality Improvement Strategies to Increase Human Papillomavirus (HPV) Vaccination
Description

HPV vaccination is at lower levels than the national goals. This study will evaluate the effectiveness of quality improvement strategies for increasing HPV vaccination coverage among adolescents in primary care clinics.

TERMINATED
DNA Plasmid-encoding Interleukin-12/HPV DNA Plasmids Therapeutic Vaccine INO-3112 and Durvalumab in Treating Patients With Recurrent or Metastatic Human Papillomavirus Associated Cancers
Description

This phase II trial studies how well deoxyribonucleic acid (DNA) plasmid-encoding interleukin-12/human papillomavirus (HPV) DNA plasmids therapeutic vaccine INO-3112 and durvalumab work in treating patients with human papillomavirus associated cancers that have come back or spread to other places in the body. Vaccines made from a gene-modified virus may help the body build an effective immune response to kill tumor cells. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving DNA plasmid-encoding interleukin-12/HPV DNA plasmids therapeutic vaccine INO-3112 and durvalumab may work better in treating patients with human papillomavirus associated cancers.

TERMINATED
Zinc Sulfate for Human Papillomavirus (HPV)
Description

The Human Papillomavirus (HPV) is well established as the primary causative agent in both warts and cervical cancer. Although cervical high risk HPV (hrHPV) infections have a high rate of spontaneous resolution this takes time and the infection can cause cervical cells to progress to precancerous and cancerous lesions. Zinc has been shown to play a central role in immunity. This study is to determine if oral zinc sulfate can improve clearance rates of high risk HPV versus placebo.

RECRUITING
Occupational Exposure to Human Papilloma Virus (HPV) and Prophylactic Vaccination
Description

Currently there are no standards for healthcare worker vaccination with the HPV, Gardasil-9 vaccine. For health care workers, the CDC only recommends for vaccination against hepatitis B, influenza virus, Measles, Mumps and Rubella (MMR), Chickenpox (Varicella), Tetanus, Diptheria, and Pertussis (Tdap), and meninogococcal infections6

ACTIVE_NOT_RECRUITING
Major De-escalation to 30 Gy for Select Human Papillomavirus Associated Oropharyngeal Carcinoma
Description

The purpose of this study is to demonstrate that participants with HPV positive and hypoxia negative T1-2, N1-2c (AJCC, 7th ed.) oropharyngeal squamous cell carcinoma receiving a major de-escalated radiation therapy with 2 cycles of standard chemotherapy is not inferior to comparable subjects treated with the current standard chemoradiation. Accrual for Cohort A has been completed. Cohort B is active and continues to enroll participants where surgery is optional and proton is allowed.

COMPLETED
Study of Topical ABI-1968 in Subjects With Precancerous Cervical Lesions From Human Papillomavirus (HPV) Infection
Description

This study evaluates the use of topical ABI-1968 cream, in the treatment of cervical precancerous lesions in adult women.

COMPLETED
Study of Topical ABI-1968 in Subjects With Precancerous Anal Lesions Resulting From Human Papillomavirus (HPV) Infection
Description

This study evaluates the use of ABI-1968, a topical cream, in the treatment of anal precancerous lesions in adults with and without human immunodeficiency virus (HIV) infection.