Clinical Trials for Cervical Cancer

HERTHENA-PanTumor01 (U31402-277): A Phase 2, Multicenter, Multicohort, Open-Label, Proof of Concept Study of Patritumab Deruxtecan (HER3-DXd; U3-1402) in Subjects With Locally Advanced or Metastatic Solid Tumors

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

HealthScout AI summary: Adults with measurable, unresectable locally advanced or metastatic solid tumors that have progressed after standard therapies, enrolled in tumor-specific refractory cohorts (e.g., melanoma post–PD-(L)1, SCCHN post platinum/PD-(L)1, HER2-negative gastric/GEJ, HGS ovarian, cervical, endometrial, urothelial, ESCC, pancreatic, mCRPC, nonsquamous NSCLC without drivers, and HR+/HER2– breast cancer after CDK4/6 and chemo). Single-arm therapy is patritumab deruxtecan (HER3-DXd) 5.6 mg/kg IV q3w, an HER3-targeted antibody–drug conjugate delivering a topoisomerase I inhibitor (DXd).

ClinicalTrials.gov ID: NCT06172478

A Phase II Trial of T Cell Receptor Gene Therapy Targeting Human Papillomavirus ( HPV) 16 E7 for HPV-Associated Cancers

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

HealthScout AI summary: Adults with metastatic or recurrent HPV16-positive cancers (e.g., cervical, oropharyngeal, anal, vulvar, vaginal, penile) who are HLA-A*02:01–positive receive lymphodepleting cyclophosphamide/fludarabine, a single infusion of autologous T cells engineered with a high-avidity TCR targeting HPV16 E7(11–19), followed by high-dose IL-2. Designed for patients post standard therapy or who declined it; controlled brain metastases allowed.

ClinicalTrials.gov ID: NCT05686226

A Phase II Study of agenT-797 (Invariant Natural Killer T Cells), Botensilimab, a Novel Fc-enhanced CTLA-4 Inhibitor, Plus Balstilimab (Anti-PD-1) With Ramucirumab and Paclitaxel for Patients With Previously Treated, Advanced Esophageal, Gastric, or Gastro-esophageal Junction Adenocarcinoma

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

HealthScout AI summary: Adults with unresectable/metastatic esophageal, gastric, or GEJ adenocarcinoma after one prior line (or relapse ≤6 months after perioperative therapy), ECOG 0–1, receive ramucirumab plus paclitaxel combined with investigational immunotherapies: agenT‑797 (allogeneic invariant NKT cell therapy targeting CD1d-presented glycolipids), botensilimab (Fc‑enhanced CTLA‑4 inhibitor), and balstilimab (PD‑1 inhibitor). Excludes prior ramucirumab, recent taxane, severe prior irAEs from PD‑(L)1/CTLA‑4, active CNS mets, significant neuropathy, or active viral infections.

ClinicalTrials.gov ID: NCT06251973

A Phase 3, Multicenter, Randomized, Open-label Study of Ifinatamab Deruxtecan (I-DXd) in Subjects With Pretreated Advanced or Metastatic Esophageal Squamous Cell Carcinoma (ESCC) (IDeate-Esophageal01)

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

HealthScout AI summary: Adults with unresectable or metastatic ESCC after exactly one prior platinum-based chemo plus immune checkpoint inhibitor are randomized to ifinatamab deruxtecan, a B7-H3–targeted antibody–drug conjugate delivering a topoisomerase I inhibitor, versus investigator’s choice of docetaxel, paclitaxel, or irinotecan. Key eligibility includes ECOG 0–1, measurable disease, and exclusion of prior B7‑H3 or topo I agents and significant ILD/pneumonitis or CNS disease.

ClinicalTrials.gov ID: NCT06644781

An Open-Label, Phase II, Randomized, Controlled Study of Danvatirsen Plus Pembrolizumab Compared to Pembrolizumab Alone in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

HealthScout AI summary: Adults with PD-L1–positive (CPS ≥1) recurrent or metastatic HNSCC (non-nasopharyngeal), no prior systemic therapy for metastatic disease, ECOG 0–1, are randomized to pembrolizumab alone versus pembrolizumab plus danvatirsen, an investigational antisense oligonucleotide targeting STAT3 mRNA to reduce STAT3 and potentially enhance antitumor immunity. Key exclusions include prior PD-(L)1 therapy, active autoimmune disease requiring treatment, brain metastases, significant immunosuppression/infections, and uncontrolled cardiovascular disease.

ClinicalTrials.gov ID: NCT05814666

An Open-label Phase II/III Randomized Trial of BNT113 in Combination With Pembrolizumab Versus Pembrolizumab Monotherapy as a First Line Therapy in Patients With Unresectable Recurrent, or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) Which is Positive for Human Papilloma Virus 16 (HPV16+) and Expresses PD-L1

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

HealthScout AI summary: Adults with unresectable recurrent or metastatic HPV16-positive, PD-L1 CPS ≥1 HNSCC (non-nasopharyngeal), treatment-naïve in the R/M setting, are randomized to pembrolizumab alone versus pembrolizumab plus BNT113, an investigational HPV16 E6/E7 mRNA lipoplex vaccine designed to activate dendritic cells and elicit HPV16-specific T-cell responses. Requires measurable disease and available tumor tissue; prior systemic therapy for locally advanced disease allowed if completed >180 days before randomization.

ClinicalTrials.gov ID: NCT04534205

A Phase 2, Randomized, Open-label, Platform Study Using a Master Protocol to Evaluate Novel Immunotherapy Combinations as First-Line Treatment in Participants With Recurrent/Metastatic PD-L1 Positive Squamous Cell Carcinoma of the Head and Neck

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

HealthScout AI summary: Adults with PD-L1–positive recurrent/metastatic HNSCC (non-nasopharyngeal), ECOG 0–1, no prior systemic therapy for R/M disease, are randomized to dostarlimab (anti–PD-1) alone or in combinations targeting the CD226 axis: belrestotug (anti-TIGIT IgG1), nelistotug (anti-CD96 IgG1), triple dostarlimab+belrestotug+nelistotug, or GSK4381562/SRF813 (anti-PVRIG IgG1). Aims to test whether dual or triple checkpoint blockade improves response versus PD-1 monotherapy in first-line PD-L1–positive HNSCC.

ClinicalTrials.gov ID: NCT06062420

Randomized Phase 2 Clinical Trial of Repeated Intratumoral and Cervical Perilymphatic Lerapolturev Injections Versus Lomustine in Recurrent Glioblastoma (GBM)

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

HealthScout AI summary: Adults with recurrent supratentorial glioblastoma after prior chemoradiation and maximal safe resection are randomized to lerapolturev (PVSRIPO)—an intratumoral/oncolytic poliovirus-rhinovirus chimera targeting CD155 with proposed oncolysis and innate/T-cell immune activation—given via two postoperative CED infusions plus serial cervical perilymphatic SC injections, versus standard lomustine. Key exclusions include infratentorial/leptomeningeal disease, high steroid requirement, and lack of polio vaccination/booster.

ClinicalTrials.gov ID: NCT06177964

A Phase 2, Randomized, Multicenter, Open-label, Study of FID-007 in Combination With Cetuximab in Patients With Advanced Head and Neck Squamous Cell Carcinoma

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

HealthScout AI summary: Adults with recurrent/metastatic HNSCC (non–EBV+ NP) after progression on PD-(L)1 therapy, ECOG 0–1, and no prior cetuximab/taxane in the R/M setting receive nanoencapsulated paclitaxel FID-007 (poly(2-ethyl-2-oxazoline) carrier; microtubule-stabilizer) plus fixed-dose cetuximab, comparing two FID-007 dose schedules. Key exclusions include >1 prior systemic R/M line, significant neuropathy, active/untreated brain mets, and strong CYP2C8/3A4 modifier use around PK sampling.

ClinicalTrials.gov ID: NCT06332092

A Phase II Study of ACR-368 and Low Dose Gemcitabine Combination Therapy in Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

HealthScout AI summary: Adults with recurrent or metastatic HNSCC (oral cavity, oropharynx, larynx, hypopharynx, including p16/HPV+ unknown primary) after prior PD-1/PD-L1 therapy receive the CHK1/2 inhibitor ACR-368 (prexasertib) plus ultra–low-dose gemcitabine every 2 weeks, with separate cohorts by p16/HPV status. Requires measurable disease, ECOG 0–1, recent tissue for p16/HPV and OncoSignature, and biopsy willingness; key toxicities expected are transient high-grade myelosuppression.

ClinicalTrials.gov ID: NCT06597565