Trial · NCT04287868
Combination Immunotherapy in Subjects With Advanced HPV Associated Malignancies
NCT04287868, Phase 1, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2023-11-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Combination Immunotherapy in Subjects With Advanced HPV Associated Malignancies. Trials, record NCT04287868. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04287868
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Combination Immunotherapy in Subjects With Advanced HPV Associated Malignancies
- NCT number
- NCT04287868
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 51 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Cervical Cancer, HPV Cancers, Anal Cancer, Oropharyngeal Cancer, Vulvar, Vaginal, Penile, Rectal Cancer
- Interventions
- PDS0101, M7824, NHS-IL12
- First posted
- 2020-02-27
- Last updated
- 2026-06-30
- Results first posted
- 2023-11-18
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Best Overall Response (BOR) in Checkpoint Naive and Immune Checkpoint Blockade (ICB) Resistant Disease in Participants With Advanced or Metastatic Human Papillomavirus (HPV) Associated Malignancies | 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. |
| Secondary | Number of Participants With Grades 1, 2, 3, 4 and/or 5 Treatment Related Adverse Events | 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. |
| Secondary | Progression-Free Survival (PFS) Time | PFS is defined as the time from the date of first treatment to the date of disease progression or death (any cause) whichever occurs first, up to 53 months | PFS is defined as the time from the date of first treatment to the date of disease progression or death (any cause) whichever occurs first. Participants who do not have disease progression or have not died at the end of follow up will be censored at the last known date the participant was progression free. Progression was assessed according to 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. |
| Secondary | Overall Survival (OS) | The time from the date of first treatment to the date of death (any cause), up to 67 months | OS will be evaluated using Kaplan-Meier methods and is defined as the time from the date of first treatment to the date of death (any cause). Participants who are alive at the end of follow up will be censored at the last known date alive. |
| Secondary | Ratio of Participants That Are Hospitalized Because of Adverse Events Attributed to Disease Progression. | 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. |
| Secondary | Number of Treatment Related Grades 1, 2, 3, 4 and/or 5 Adverse Events | 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. |
| Secondary | Duration of Response (DOR) | 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 lesions, taking as reference the baseline sum of diameters. 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. |
| Other | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) | 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 one of the previous outcomes mentioned. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Best Overall Response (BOR) in Checkpoint Naive and Immune Checkpoint Blockade (ICB) Resistant Disease in Participants With Advanced or Metastatic Human Papillomavirus (HPV) Associated Malignancies | Every 2 months, up to approximately 10 months | 48 participants were screened for Cohort (C)1, 1 was a screen fail =\> 47 were treated on C1. 3 participants were screened for C2 and were treated on it. 50 participants (47 in C1 and 3 in C2) comprise the complete treated population (All participants). As pre-specified by the protocol cohort 2 is not required to be reported independently. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Grades 1, 2, 3, 4 and/or 5 Treatment Related Adverse Events | Date treatment consent signed to date off study, approximately 34 months and 20 days. | Pre-specified in the protocol for cohort 1 only. 1/48 participants in cohort 1 was a screening fail. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression-Free Survival (PFS) Time | PFS is defined as the time from the date of first treatment to the date of disease progression or death (any cause) whichever occurs first | |||
| SECONDARY | Overall Survival (OS) | The time from the date of first treatment to the date of death (any cause) | |||
| SECONDARY | Ratio of Participants That Are Hospitalized Because of Adverse Events Attributed to Disease Progression. | While participant on study; an average of 3 months | Proportion of participants | NUMBER | |
| SECONDARY | Number of Treatment Related Grades 1, 2, 3, 4 and/or 5 Adverse Events | Date treatment consent signed to date off study, approximately 34 months and 20 days. | Pre-specified in the protocol for cohort 2 only. | adverse events | NUMBER |
| SECONDARY | Duration of Response (DOR) | At disease progression, an average of 10 months | 1/48 participants in cohort 1 was a screening fail. | Months | MEDIAN |
| OTHER_PRE_SPECIFIED | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) | Date treatment consent signed to date off study, approximately 34 months and 20 days. | 1/48 participants in cohort 1 was a screening fail. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Best Overall Response (BOR) in Checkpoint Naive and Immune Checkpoint Blockade (ICB) Resistant Disease in Participants With Advanced or Metastatic Human Papillomavirus (HPV) Associated Malignancies | All Participants | Complete Response | 4 | Participants | |
| Best Overall Response (BOR) in Checkpoint Naive and Immune Checkpoint Blockade (ICB) Resistant Disease in Participants With Advanced or Metastatic Human Papillomavirus (HPV) Associated Malignancies | Participants With Human Papillomavirus 16 (HPV16+) Tumors | Complete Response | 4 | Participants | |
| Best Overall Response (BOR) in Checkpoint Naive and Immune Checkpoint Blockade (ICB) Resistant Disease in Participants With Advanced or Metastatic Human Papillomavirus (HPV) Associated Malignancies | Human Papillomavirus 16 Tumors (HPV-16+), Immune Checkpoint Blockade (ICB) - Naive | Complete Response | 2 | Participants | |
| Best Overall Response (BOR) in Checkpoint Naive and Immune Checkpoint Blockade (ICB) Resistant Disease in Participants With Advanced or Metastatic Human Papillomavirus (HPV) Associated Malignancies | Human Papillomavirus 16 Tumors (HPV-16+), Immune Checkpoint Blockade (ICB) - Resistant | Complete Response | 2 | Participants | |
| Best Overall Response (BOR) in Checkpoint Naive and Immune Checkpoint Blockade (ICB) Resistant Disease in Participants With Advanced or Metastatic Human Papillomavirus (HPV) Associated Malignancies | All Participants | Partial Response | 7 | Participants | |
| Best Overall Response (BOR) in Checkpoint Naive and Immune Checkpoint Blockade (ICB) Resistant Disease in Participants With Advanced or Metastatic Human Papillomavirus (HPV) Associated Malignancies | Participants With Human Papillomavirus 16 (HPV16+) Tumors | Partial Response | 7 | Participants | |
| Best Overall Response (BOR) in Checkpoint Naive and Immune Checkpoint Blockade (ICB) Resistant Disease in Participants With Advanced or Metastatic Human Papillomavirus (HPV) Associated Malignancies | Human Papillomavirus 16 Tumors (HPV-16+), Immune Checkpoint Blockade (ICB) - Naive | Partial Response | 3 | Participants | |
| Best Overall Response (BOR) in Checkpoint Naive and Immune Checkpoint Blockade (ICB) Resistant Disease in Participants With Advanced or Metastatic Human Papillomavirus (HPV) Associated Malignancies | Human Papillomavirus 16 Tumors (HPV-16+), Immune Checkpoint Blockade (ICB) - Resistant | Partial Response | 4 | Participants | |
| Best Overall Response (BOR) in Checkpoint Naive and Immune Checkpoint Blockade (ICB) Resistant Disease in Participants With Advanced or Metastatic Human Papillomavirus (HPV) Associated Malignancies | All Participants | Overall Response rate (CR+PR) | 11 | Participants | |
| Best Overall Response (BOR) in Checkpoint Naive and Immune Checkpoint Blockade (ICB) Resistant Disease in Participants With Advanced or Metastatic Human Papillomavirus (HPV) Associated Malignancies | Participants With Human Papillomavirus 16 (HPV16+) Tumors | Overall Response rate (CR+PR) | 11 | Participants |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1, Arm 1: Human Papillomavirus (HPV) Associated Malignancies | 48 | |
| Overall Study | STARTED | Cohort 2, Arm 2: Cervical Cancer With Prior Pelvic Radiation and Boost Brachytherapy | 3 | |
| Overall Study | COMPLETED | Cohort 1, Arm 1: Human Papillomavirus (HPV) Associated Malignancies | 47 | |
| Overall Study | COMPLETED | Cohort 2, Arm 2: Cervical Cancer With Prior Pelvic Radiation and Boost Brachytherapy | 3 | |
| Overall Study | NOT COMPLETED | Cohort 1, Arm 1: Human Papillomavirus (HPV) Associated Malignancies | 1 | |
| Overall Study | NOT COMPLETED | Cohort 2, Arm 2: Cervical Cancer With Prior Pelvic Radiation and Boost Brachytherapy | 0 |
Source ClinicalTrials.gov
Adverse events600
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | Cohort 1, Arm 1: Human Papillomavirus (HPV) Associated Malignancies | 5 | 47 | 8 |
| other | Abdominal pain | Gastrointestinal disorders | Cohort 2, Arm 2: Cervical Cancer With Prior Pelvic Radiation and Boost Brachytherapy | 0 | 3 | 0 |
| other | Activated partial thromboplastin time prolonged | Investigations | Cohort 1, Arm 1: Human Papillomavirus (HPV) Associated Malignancies | 5 | 47 | 6 |
| other | Activated partial thromboplastin time prolonged | Investigations | Cohort 2, Arm 2: Cervical Cancer With Prior Pelvic Radiation and Boost Brachytherapy | 0 | 3 | 0 |
| other | Alanine aminotransferase increased | Investigations | Cohort 1, Arm 1: Human Papillomavirus (HPV) Associated Malignancies | 9 | 47 | 24 |
| other | Alanine aminotransferase increased | Investigations | Cohort 2, Arm 2: Cervical Cancer With Prior Pelvic Radiation and Boost Brachytherapy | 1 | 3 | 3 |
| other | Alkaline phosphatase increased | Investigations | Cohort 1, Arm 1: Human Papillomavirus (HPV) Associated Malignancies | 9 | 47 | 16 |
| other | Alkaline phosphatase increased | Investigations | Cohort 2, Arm 2: Cervical Cancer With Prior Pelvic Radiation and Boost Brachytherapy | 1 | 3 | 1 |
| other | Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | Cohort 1, Arm 1: Human Papillomavirus (HPV) Associated Malignancies | 2 | 47 | 2 |
| other | Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | Cohort 2, Arm 2: Cervical Cancer With Prior Pelvic Radiation and Boost Brachytherapy | 0 | 3 | 0 |
1 to 10 of 600Source ClinicalTrials.gov
See all 600 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1, Arm 1: Human Papillomavirus (HPV) Associated Malignancies | 28 | 47 |
| Total, all-cause mortality | Cohort 2, Arm 2: Cervical Cancer With Prior Pelvic Radiation and Boost Brachytherapy | 0 | 3 |
| Total, other adverse events | Cohort 1, Arm 1: Human Papillomavirus (HPV) Associated Malignancies | 47 | 47 |
| Total, other adverse events | Cohort 2, Arm 2: Cervical Cancer With Prior Pelvic Radiation and Boost Brachytherapy | 3 | 3 |
| Total, serious adverse events | Cohort 1, Arm 1: Human Papillomavirus (HPV) Associated Malignancies | 18 | 47 |
| Total, serious adverse events | Cohort 2, Arm 2: Cervical Cancer With Prior Pelvic Radiation and Boost Brachytherapy | 1 | 3 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39976981 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Cohort 1, Arm 1: Human Papillomavirus (HPV) Associated Malignancies vs Cohort 2, Arm 2: Cervical Cancer With Prior Pelvic Radiation and Boost Brachytherapy: Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) | Trial comparisons |
| Cohort 1, Arm 1: Human Papillomavirus (HPV) Associated Malignancies vs Cohort 2, Arm 2: Cervical Cancer With Prior Pelvic Radiation and Boost Brachytherapy: deaths from any cause | Trial comparisons |
| Cohort 1, Arm 1: Human Papillomavirus (HPV) Associated Malignancies vs Cohort 2, Arm 2: Cervical Cancer With Prior Pelvic Radiation and Boost Brachytherapy: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04287868
GET https://conductscience.org/api/trials/v1/NCT04287868/results?page=2