HPV Associated CancersPhase 2NCT07090174
CASCADE: Testing for Safety and Immune Effects of PDS0101, an Anti-HPV Therapy, Among People Living With HIV
A Phase 2 study testing PDS0101 in people with HPV Associated Cancers and HIV (Human Immunodeficiency Virus), run by University of California, San Diego at 3 sites in 2 countries.
Trial summary
This study is testing the immunotherapeutic agent, PDS0101, in adults living with HIV who are also infected with human papillomavirus (HPV) type 16. The purpose of the study is to learn whether PDS0101 is safe and whether it can help the body's immune system respond to HPV 16. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- HPV Associated Cancers, HIV (Human Immunodeficiency Virus), Anal Cancer
- What is being tested?
- PDS0101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 30 Apr 2026to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HPV 16 detected on anal swab, cervical swab or vaginal swab ≤90 days of registration. (Note: HPV 16 detected on this swab can be from the screening evaluation or through standard of care assessments. The HPV 16 assay must be FDA-cleared and report HPV 16 results separately. The assay must be performed in a CLIA-certified laboratory.)
- Cervical HSIL cohort: CIN III/carcinoma in situ (CIS), CIN II/III, or CIN II with positive p16 stain diagnosed on cervical biopsy ≤90 days of registration and detection of cervical or vaginal HPV 16.
- Cervical HSIL cohort: HSIL must occupy <50% circumference of the cervical squamocolumnar junction, and adequate colposcopy with visualization of the endocervical HSIL margins. (Note: Participants with cervical HSIL occupying ≥50% of the circumference of cervical squamocolumnar junction and/or inadequate visualization of the endocervical HSIL margins are not eligible for this protocol.)
- Anal HSIL cohort: anal intraepithelial neoplasia (AIN) III, AIN II/III, or AIN II with positive p16 stain diagnosed on anal or perianal biopsy ≤90 days of registration and detection of anal HPV 16.
- Anal HSIL cohort: HSIL must occupy <50% circumference of the squamocolumnar junction. (Note: Participants with anal HSIL occupying ≥50% of the circumference of cervical squamocolumnar junction are not eligible for this protocol.)
- ≥25 years of age.
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- HIV infection with receipt of antiretroviral therapy for at least 12 months.
- CD4+ T-cell count ≥200 cells/mm3 ≤45 days of registration.
- Plasma HIV-1 RNA <200 copies/mL ≤45 days of registration.
- Participants must meet the following laboratory parameters ≤45 days before enrollment:
- Absolute neutrophil count: ≥1,500/mm3
- Platelets: ≥100,000/mm3
- Hemoglobin >12.5 g/dL for men and >11.5 g/dL for women
- Estimated glomerular filtration rate (eGFR) >70 mL/min/1.73m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-Epi) equation or serum creatinine <1.2 x upper limit of normal (ULN)
- Aspartate aminotransferase (AST) (SGOT), and alanine aminotransferase (ALT) (SGPT), <1.5 x ULN
- Total bilirubin <1.5 x ULN
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1 (or Karnofsky ≥70%).
- Willingness to comply with three-dose immunotherapeutic agent schedule and subsequent study visits.
- The effects of PDS0101 on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, women of child-bearing potential (WOCBP) and men must agree to use adequate contraception prior to study entry and for at least 120 days after the last dose of study treatment. Women of childbearing potential must have a negative urine pregnancy test (β-human chorionic gonadotropin) within 24 hours prior to registration and prior to visits on Days 1, 22, 43, 57, and 127. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately and will not receive any additional doses of immunotherapeutic agent. Women who become pregnant and partners of male participants who become pregnant will be followed to assess pregnancy outcomes.
- Ability to understand and the willingness to sign a written informed consent form (ICF).
Who cannot join
- AIDS-defining condition within 6 months prior to study entry.
- Receipt of blood products within 6 months of enrollment or are currently taking immune suppressants.
- History of HPV-related cancer or suspected cancer of the cervix, anus, vagina, vulva, penis, or oropharynx.
- Current diagnosis of cancer or prior invasive cancer > T1 stage (other than non-melanoma skin cancer) that has required active treatment within the past 3 years.
- Suspicion of invasive cancer of the cervix, vulva, vagina, perianus or anal canal. (Note: Concomitant vulvar, vaginal, or perianal HSIL is not exclusionary.)
- Surgical or ablative treatment for anal or cervical HSIL within 180 days of study entry.
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- Prior receipt of any doses of a licensed or experimental HPV immunotherapeutic agent. (Note: Prior receipt of licensed prophylactic HPV vaccines is permitted.)
- Planned use of intravaginal, vulvar, perianal or intra-anal imiquimod or 5-fluorouracil or another topical therapeutic agent with possible activity against HPV disease, or their use within ≤90 days of entry.
- Receipt of a live vaccine within 30 days prior to the first dose of treatment. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed. Coordination and timing of COVID-19 vaccination should be based on local Investigator clinical assessment and judgment.
- Received immunotherapy/immunomodulatory or immunosuppressive agents (e.g., IFNs, tumor necrosis factor, interleukins, immunoglobulins or other biological response modifiers [GM-CSF, granulocyte-macrophage colony-stimulating factor]) within 6 weeks prior to administration of the first study treatment.
- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 30 days prior to the first dose of study treatment. (Note: Participants who entered the follow-up phase of an investigational study may participate as long as it has been 30 days after the last dose of the previous investigational agent.)
- Is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug. Current or recent use of intra-articular, topical, or inhaled corticosteroids is acceptable.
- Participants known to be positive for Hepatitis B antigen (HBsAg)/Hepatitis B virus (HBV) DNA or active Hepatitis C. Active Hepatitis C (HCV) is defined by a known positive HCV antibody result and known quantitative HCV RNA results greater than the lower limits of detection of the assay.
- Plan to relocate during study period.
- Acute medical conditions that would require exclusion from participation based on the opinion of the supervising physician.
- Potential participants receiving any other investigational agents may be excluded in the opinion of the supervising physician.
- Use of opioids within 2 weeks prior to enrollment. (Note: Medically assisted therapy for opioid use disorder or alcohol use disorder (e.g., stable methadone or buprenorphine/naloxone) are not exclusionary. The rationale for excluding other opioid use is to allow appropriate grading of injection-related pain.)
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Current bacterial sexually transmitted infection (STI) requiring treatment (participants may participate after adequate treatment, at the discretion of the treating provider).
- Pregnant or breastfeeding, unwilling/unable to use contraception, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of any study treatment.
- For the purpose of this study, a WOCBP (i.e., fertile) is defined as the period following menarche and until becoming post-menopausal unless permanently sterile. Acceptable methods of birth control for this study include: i) Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.
- A post-menopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the post-menopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.
- Use of a barrier (diaphragm or condom) with spermicide iv) Combined hormonal (estrogen and progestogen) contraception associated with inhibition of ovulation v) An intrauterine device/system vi. An oral, transdermal, or injectable contraceptive vii. A vasectomized partner is a highly effective birth control method provided that partner is the sole sexual partner of the WOCBP trial participant and that the vasectomized partner has received medical assessment of the surgical success.
- For the purpose of this study, a man is considered fertile after puberty unless permanently sterile by bilateral orchidectomy.
- Male participants must agree to use a condom as an effective method of contraception throughout the study and for at least 120 days after the last dose of study treatment.
- Use of anticoagulants other than non-steroidal anti-inflammatory drugs or aspirin.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Weill Cornell Medical College
New York, New York, 10010
Montefiore Medical Center/Albert Einstein College of Medicine
The Bronx, New York, 10461
About this study
Official title: CASCADE: A Single-Arm, Open-Label Clinical Phase II Trial of the Safety and Immunogenicity of PDS0101 in People Living With HIV
This study is testing the immunotherapeutic agent, PDS0101, in adults living with HIV who are also infected with human papillomavirus (HPV) type 16. The purpose of the study is to learn whether PDS0101 is safe and whether it can help the body's immune system respond to HPV 16. Researchers will enroll 27 adults, at least 25 years of age, who have been receiving antiretroviral therapy (ART) for at least 12 months, have a cluster of differentiation 4 (CD4) cell count of at least 200 cells/mm³, and have an HIV viral load below 200 copies/mL. All participants must have HPV 16 detected in the cervix, vagina, or anus. Some participants will have high-grade squamous intraepithelial lesions (HSIL), a condition that can lead to cancer. At least 10 participants will have cervical HSIL, and at least 10 will have anal HSIL. Participants with both cervical and anal HSIL will count in both groups. Others may have HPV 16 without HSIL.
This is a single-arm, open-label trial, which means that all participants will receive the same treatment, and both the investigators and the participants will know what the treatment is. Each participant will receive three doses of PDS0101. Participants who receive at least one dose will be included in the study's main safety analysis. If a participant does not receive all three doses and does not experience a serious side effect related to PDS0101 (defined as a Grade 3 or higher toxicity), that participant may be replaced to make sure that 27 participants either complete the full vaccination schedule or experience a primary safety event. Participants who do have a qualifying safety event will not be replaced. Even if someone stops the study early, their data will still be included in the final analysis.
The main goals of this study are to evaluate the safety of PDS0101 and to measure the immune response it produces. The safety evaluation includes monitoring for serious or unexpected side effects, especially those that are Grade 3 or higher in severity. The immune response will be assessed by looking at how the body's T cells respond to HPV 16 after PDS0101 administration. The total time a participant is involved in the study includes the PDS0101 administration period and several follow-up visits, which may take place over the course of several months. This research may help inform future strategies for preventing or treating HPV-related disease in people living with HIV.
- Conditions
- HPV Associated Cancers, HIV (Human Immunodeficiency Virus), Anal Cancer, Cervical Cancer, HPV 16 Infection
- Being tested
- PDS0101
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Anus Neoplasms, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PDS0101Biological
Also called Versamune® + HPVmix
PDS0101 is an HPV 16-targeted immunotherapy administered as two subcutaneous injections of 0.5 mL each (total 1.0 mL). Each dose contains 3.0 mg of Versamune®, a proprietary cationic lipid nanoparticle adjuvant, and 2.7 mg of HPVmix, a blend of HPV16 E6 and E7 proteins. Versamune® enhances antigen uptake and dendritic cell activation, promoting T-cell priming and memory formation. In preclinical studies, subcutaneous administration resulted in low systemic bioavailability (<6%) and efficient dendritic cell uptake, consistent with a favorable safety profile. PDS0101 has been studied in a completed Phase I trial in HIV-uninfected women with high-risk HPV and cervical intraepithelial neoplasia (CIN) I. Each participant in this study will receive three doses, spaced 21 days apart (± 7 days) unless there has been Grade 3 or greater toxicity at least possibly related to the study agent.
| Study group | Role | What they receive |
|---|---|---|
| PDS0101 HPV 16 immunotherapeutic agent | Experimental | Not described Receives: Biological: PDS0101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Number of Grade 3 or greater adverse events (AE) at least possibly related to PDS0101.
Adverse events will be scored according to CTCAE v5.0 grading (Grade 1-Mild, Grade 2-Moderate, Grade 3-Severe, Grade 4-Life-threatening, and Grade 5-Fatal) except for injection site reactions (ISRs) grading, wherein they will be reviewed against 2007 FDA guidance. Skin discoloration is common with PDS0101, therefore skin discoloration (ISRs including erythema or pigment changes) >10 cm and induration >10 cm will not count as a primary safety endpoint. However, all of the detailed AEs will be reported as a supporting analysis including all ISRs. For the primary safety analysis, we will include all participants who receive at least one dose of PDS0101. Participants who only receive 1-2 doses who discontinue PDS0101/study participation for reasons other than a primary safety event will be replaced to assure 27 participants who receive all 3 doses or discontinue PDS0101 after 1-2 doses because of a primary safety event; those with primary safety event after 1-2 doses won't be replaced.
Measured: 127 days
Tolerability: Proportion of participants who receive all three doses.
Participants who do not receive the first dose will be excluded from all analyses.
Measured: 127 days
Secondary outcomes (1)
Proportion of participants with an immunotherapeutic agent-induced response.
Immunotherapeutic agent-induced response is defined as a ≥ 3-fold increase over baseline at ≥ 1 of the 4 post-dose administration visits by either interferon gamma (IFN-γ) or granzyme ELISPOT assays, with background subtracted. The proportion with a response by each assay will be reported separately and at each post-study immunotherapeutic agent administration visit.
Measured: 127 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start30 Apr 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Why it stopped: Study withdrawn prior to participant enrollment due to lack of study product.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPV Associated CancersStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- University of Puerto Rico, Montefiore Medical Center, Albert Einstein College of Medicine, H. Lee Moffitt Cancer Center and Research Institute, National Cancer Institute (NCI), Weill Medical College of Cornell University, Emory University, University of Maryland, Baltimore, Frontier Science & Technology Research Foundation, Inc.
- Responsible party
- Principal investigator, Timothy Wilkin, University of California, San Diego
- Investigators
- Timothy Wilkin, MD, MPH, Principal investigator, University of California, San DiegoTimothy Wilkin, MD, MPH, Study chair, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07090174
- Sponsor's protocol ID
- 812691
- Other IDs
- UG1CA275414, UG1CA284884, UG1CA284883, U24CA275417, C2003
- Status last verified
- Aug 2026
- First submitted
- 22 Jul 2025
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie results in the publication.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CASCADE: A Single-Arm, Open-Label Clinical Phase II Trial of the Safety and Immunogenicity of PDS0101 in People Living With HIV
- ClinicalTrials.gov ID
- NCT07090174
- Acronym / sponsor ID
- 812691
- Conditions
- HPV Associated Cancers, HIV (Human Immunodeficiency Virus), Anal Cancer, Cervical Cancer, HPV 16 Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study withdrawn prior to participant enrollment due to lack of study product.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- University of Puerto Rico, Montefiore Medical Center, Albert Einstein College of Medicine, H. Lee Moffitt Cancer Center and Research Institute, National Cancer Institute (NCI), Weill Medical College of Cornell University, Emory University, University of Maryland, Baltimore, Frontier Science & Technology Research Foundation, Inc.
- Study start
- 30 Apr 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 29 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is testing the immunotherapeutic agent, PDS0101, in adults living with HIV who are also infected with human papillomavirus (HPV) type 16. The purpose of the study is to learn whether PDS0101 is safe and whether it can help the body's immune system respond to HPV 16. Researchers will enroll 27 adults, at least 25 years of age, who have been receiving antiretroviral therapy (ART) for at least 12 months, have a cluster of differentiation 4 (CD4) cell count of at least 200 cells/mm³, and have an HIV viral load below 200 copies/mL. All participants must have HPV 16 detected in the cervix, vagina, or anus. Some participants will have high-grade squamous intraepithelial lesions (HSIL), a condition that can lead to cancer. At least 10 participants will have cervical HSIL, and at least 10 will have anal HSIL. Participants with both cervical and anal HSIL will count in both groups. Others may have HPV 16 without HSIL.
This is a single-arm, open-label trial, which means that all participants will receive the same treatment, and both the investigators and the participants will know what the treatment is. Each participant will receive three doses of PDS0101. Participants who receive at least one dose will be included in the study's main safety analysis. If a participant does not receive all three doses and does not experience a serious side effect related to PDS0101 (defined as a Grade 3 or higher toxicity), that participant may be replaced to make sure that 27 participants either complete the full vaccination schedule or experience a primary safety event. Participants who do have a qualifying safety event will not be replaced. Even if someone stops the study early, their data will still be included in the final analysis.
The main goals of this study are to evaluate the safety of PDS0101 and to measure the immune response it produces. The safety evaluation includes monitoring for serious or unexpected side effects, especially those that are Grade 3 or higher in severity. The immune response will be assessed by looking at how the body's T cells respond to HPV 16 after PDS0101 administration. The total time a participant is involved in the study includes the PDS0101 administration period and several follow-up visits, which may take place over the course of several months. This research may help inform future strategies for preventing or treating HPV-related disease in people living with HIV.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PDS0101 HPV 16 immunotherapeutic agent | Experimental | Biological: PDS0101 |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- HPV 16 detected on anal swab, cervical swab or vaginal swab ≤90 days of registration. (Note: HPV 16 detected on this swab can be from the screening evaluation or through standard of care assessments. The HPV 16 assay must be FDA-cleared and report HPV 16 results separately. The assay must be performed in a CLIA-certified laboratory.)
- Cervical HSIL cohort: CIN III/carcinoma in situ (CIS), CIN II/III, or CIN II with positive p16 stain diagnosed on cervical biopsy ≤90 days of registration and detection of cervical or vaginal HPV 16.
- Cervical HSIL cohort: HSIL must occupy <50% circumference of the cervical squamocolumnar junction, and adequate colposcopy with visualization of the endocervical HSIL margins. (Note: Participants with cervical HSIL occupying ≥50% of the circumference of cervical squamocolumnar junction and/or inadequate visualization of the endocervical HSIL margins are not eligible for this protocol.)
- Anal HSIL cohort: anal intraepithelial neoplasia (AIN) III, AIN II/III, or AIN II with positive p16 stain diagnosed on anal or perianal biopsy ≤90 days of registration and detection of anal HPV 16.
- Anal HSIL cohort: HSIL must occupy <50% circumference of the squamocolumnar junction. (Note: Participants with anal HSIL occupying ≥50% of the circumference of cervical squamocolumnar junction are not eligible for this protocol.)
Key exclusion criteria (25 listed)
- AIDS-defining condition within 6 months prior to study entry.
- Receipt of blood products within 6 months of enrollment or are currently taking immune suppressants.
- History of HPV-related cancer or suspected cancer of the cervix, anus, vagina, vulva, penis, or oropharynx.
- Current diagnosis of cancer or prior invasive cancer > T1 stage (other than non-melanoma skin cancer) that has required active treatment within the past 3 years.
- Suspicion of invasive cancer of the cervix, vulva, vagina, perianus or anal canal. (Note: Concomitant vulvar, vaginal, or perianal HSIL is not exclusionary.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PDS0101Also: Versamune® + HPVmixPDS0101 is an HPV 16-targeted immunotherapy administered as two subcutaneous injections of 0.5 mL each (total 1.0 mL). Each dose contains 3.0 mg of Versamune®, a proprietary cationic lipid nanoparticle adjuvant, and 2.7 mg of HPVmix, a blend of HPV16 E6 and E7 proteins. Versamune® enhances antigen uptake and dendritic cell activation, promoting T-cell priming and memory formation. In preclinical studies, subcutaneous administration resulted in low systemic bioavailability (<6%) and efficient dendritic cell uptake, consistent with a favorable safety profile. PDS0101 has been studied in a completed Phase I trial in HIV-uninfected women with high-risk HPV and cervical intraepithelial neoplasia (CIN) I. Each participant in this study will receive three doses, spaced 21 days apart (± 7 days) unless there has been Grade 3 or greater toxicity at least possibly related to the study agent. | Biological | PDS0101 HPV 16 immunotherapeutic agent |
Primary outcome
Safety: Number of Grade 3 or greater adverse events (AE) at least possibly related to PDS0101.
Time frame: 127 days
Adverse events will be scored according to CTCAE v5.0 grading (Grade 1-Mild, Grade 2-Moderate, Grade 3-Severe, Grade 4-Life-threatening, and Grade 5-Fatal) except for injection site reactions (ISRs) grading, wherein they will be reviewed against 2007 FDA guidance. Skin discoloration is common with PDS0101, therefore skin discoloration (ISRs including erythema or pigment changes) >10 cm and induration >10 cm will not count as a primary safety endpoint. However, all of the detailed AEs will be reported as a supporting analysis including all ISRs. For the primary safety analysis, we will include all participants who receive at least one dose of PDS0101. Participants who only receive 1-2 doses who discontinue PDS0101/study participation for reasons other than a primary safety event will be replaced to assure 27 participants who receive all 3 doses or discontinue PDS0101 after 1-2 doses because of a primary safety event; those with primary safety event after 1-2 doses won't be replaced.
Tolerability: Proportion of participants who receive all three doses.
Time frame: 127 days
Participants who do not receive the first dose will be excluded from all analyses.
1 secondary outcome
Proportion of participants with an immunotherapeutic agent-induced response.
Time frame: 127 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie results in the publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy Wilkin, MD, MPH principal investigator
University of California, San Diego
Timothy Wilkin, MD, MPH study chair
University of California, San Diego
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PDS0101 in people with HPV Associated Cancers and HIV (Human Immunodeficiency Virus), run by University of California, San Diego at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: Number of Grade 3 or greater adverse events (AE) at least possibly related to PDS0101. (time frame: 127 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.