18 and older, any sex, with Cervical Cancer or HPV Cancers. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Best Overall Response (BOR) in Checkpoint Naive and Immune Checkpoint Blockade (ICB) Resistant Disease in Participants With Advanced or Metastatic Human Papillomavirus (HPV) Associated MalignanciesPrimary· Every 2 months, up to approximately 10 months
BOR is defined as a complete response or partial response assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Complete response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.
Complete Response
Group
Value
95% CI
All Participants
4
Participants With Human Papillomavirus 16 (HPV16+) Tumors
Number of Participants With Grades 1, 2, 3, 4 and/or 5 Treatment Related Adverse EventsSecondary· Date treatment consent signed to date off study, approximately 34 months and 20 days.
Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is death related to adverse event.
Grade 1
Group
Value
95% CI
Cohort 1, Arm 1: Human Papillomavirus (HPV) Associated Malignancies
45
Grade 2
Group
Value
95% CI
Cohort 1, Arm 1: Human Papillomavirus (HPV) Associated Malignancies
42
Grade 3
Group
Value
95% CI
Cohort 1, Arm 1: Human Papillomavirus (HPV) Associated Malignancies
25
Grade 4
Group
Value
95% CI
Cohort 1, Arm 1: Human Papillomavirus (HPV) Associated Malignancies
1
Grade 5
Group
Value
95% CI
Cohort 1, Arm 1: Human Papillomavirus (HPV) Associated Malignancies
0
Ratio of Participants That Are Hospitalized Because of Adverse Events Attributed to Disease Progression.Secondary· While participant on study; an average of 3 months
Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Progressive disease is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The appearance of one or more new lesions is also considered progressions.
Group
Value
95% CI
Cohort 1, Arm 1: Human Papillomavirus (HPV) Associated Malignancies
0.04
Cohort 2, Arm 2: Cervical Cancer With Prior Pelvic Radiation and Boost Brachytherapy
0
Number of Treatment Related Grades 1, 2, 3, 4 and/or 5 Adverse EventsSecondary· Date treatment consent signed to date off study, approximately 34 months and 20 days.
Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is death related to adverse event.
Grade 1
Group
Value
95% CI
Cohort 2, Arm 2: Cervical Cancer With Prior Pelvic Radiation and Boost Brachytherapy
3
Grade 2
Group
Value
95% CI
Cohort 2, Arm 2: Cervical Cancer With Prior Pelvic Radiation and Boost Brachytherapy
3
Grade 3
Group
Value
95% CI
Cohort 2, Arm 2: Cervical Cancer With Prior Pelvic Radiation and Boost Brachytherapy
1
Grade 4
Group
Value
95% CI
Cohort 2, Arm 2: Cervical Cancer With Prior Pelvic Radiation and Boost Brachytherapy
1
Grade 5
Group
Value
95% CI
Cohort 2, Arm 2: Cervical Cancer With Prior Pelvic Radiation and Boost Brachytherapy
0
Duration of Response (DOR)Secondary· At disease progression, an average of 10 months
DOR is measured from the time measurement criteria are met for complete response (CR) or partial response (PR) (whichever is first recorded) until the first date that progressive disease (PD) is objectively documented and is evaluated using the Kaplan-Meier method. Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Complete response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial response is at least a 30% decrease in the sum of the diameters of target
Group
Value
95% CI
Cohort 1, Arm 1: Human Papillomavirus (HPV) Associated Malignancies
10.6
3.7 – NA
Cohort 2, Arm 2: Cervical Cancer With Prior Pelvic Radiation and Boost Brachytherapy
10.2
NA – NA
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)Secondary· Date treatment consent signed to date off study, approximately 34 months and 20 days.
Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent
Group
Value
95% CI
Cohort 1, Arm 1: Human Papillomavirus (HPV) Associated Malignancies
47
Cohort 2, Arm 2: Cervical Cancer With Prior Pelvic Radiation and Boost Brachytherapy
3
Adverse events — posted to ClinicalTrials.gov
Time frame: Date treatment consent signed to date off study, approximately 34 months and 20 days..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Cohort 1, Arm 1: Human Papillomavirus (HPV) Associated Malignancies
Serious: 18/47 (38%)
Deaths: 28/47
Cohort 2, Arm 2: Cervical Cancer With Prior Pelvic Radiation and Boost Brachytherapy
Serious: 1/3 (33%)
Deaths: 0/3
Serious adverse events (34 terms)
Reaction
System
Cohort 1, Arm 1: Human Pap…
Cohort 2, Arm 2: Cervical …
Abdominal pain
Gastrointestinal disorders
—
—
Anemia
Blood and lymphatic system disorders
—
—
General disorders and administration site conditions - Other, Mucosal bleeding
Background:
More than 30,000 cases of human papillomavirus (HPV) associated cancers occur annually in the United States. When these cancers spread, they do not respond well to standard treatments and are often incurable. Researchers want to see if a mix of drugs can help.
Objective:
To learn if a mix of immunotherapy drugs can shrink tumors in people with HPV associated cancers.
Eligibility:
People ages 18 and older with locally advanced or metastatic HPV associated cancer, such as cervical cancers; cyclin-dependent kinase inhibitor 2A (P16+) oropharyngeal cancers; anal cancers; vulvar, vaginal, penile, and squamous cell rectal cancers; or other locally advanced or metastatic solid tumors (e.g., lung, esophagus) that are known HPV+ cancers
Design:
Participants will be screened with:
* medical history
* disease confirmation (or tumor biopsy)
* physical exam
* body scans (computed tomography (CT), magnetic resonance imaging (MRI), and/or nuclear)
* blood tests
* electrocardiogram (to measure the electrical activity of the heart)
* urine tests.
Participants will get PDS0101 injected under the skin every 4 weeks for 6 doses. Then they will get it every 3 months for 2 doses.
Participants will get M7824 (MSB0011395C) by intravenous infusion every 2 weeks. For this, a needle is inserted into a vein. The drug is given over a 1-hour period.
Participants will get NHS-IL12 injected under the skin every 4 weeks.
Participants will get the study drugs for up to 1 year. They will visit the NIH every 2 weeks. They will repeat the screening tests during the study.
About 28 days after treatment ends, participants will have a follow-up visit or telephone call. Then they will be contacted every 3 months for 1 year, and then every 6 months after that, for the rest of their life.
Patients with cervical cancer with prior pelvic radiation and boost brachytherapy will be enrolled in a separate cohort to evaluate safety and preliminary evidence of efficacy...
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07090174 — Testing for Safety and Immune Effects of PDS0101, an Anti-HPV Therapy, Among People Living With HIV
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Cancer Institute (NCI)
Last refreshed: 13 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04287868.