Immune Overall Response Rate
Primary
· 3 years
Overall objective Response Rate by Immune Response Evaluation Criteria in Solid Tumors (iRECIST) criteria (iORR)
| Group | Value | 95% CI |
|---|---|---|
| Treatment | 16.7 | 8.8 – 19.1 |
Last reviewed · How we verify
NCT04483544
Pembrolizumab and Olaparib in Cervical Cancer Patients
Terminated
Phase 2
Results posted
Last updated 29 April 2025
What this trial tests
Phase 2 trial testing pembrolizumab in Cervical Cancer in 8 participants. Terminated before completion.
Timeline
3 December 2020
Primary endpoint
12 December 2024
12 December 2024
12 December 2024
Quick facts
| Lead sponsor | Baptist Health South Florida |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 8 |
| Start date | 3 December 2020 |
| Primary completion | 12 December 2024 |
| Estimated completion | 12 December 2024 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- pembrolizumab (pembrolizumab) — full drug profile →
- olaparib (olaparib) — full drug profile →
Conditions studied
- Cervical Cancer — all drugs for Cervical Cancer →
- Cervical Carcinoma — all drugs for Cervical Carcinoma →
Sponsor
Baptist Health South Florida — full company profile →
Who can join
18 and older, female only, with Cervical Cancer or Cervical Carcinoma. 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.
Progression Free Survival
Secondary
· 3 years
Defined among all treated patients as the time from first dose of study drug until the first date of either disease progression or death due to any cause
| Group | Value | 95% CI |
|---|---|---|
| Treatment | 4.5 | 2.0 – NA |
Number of Patient Reporting Treatment-emergent Adverse Events (TEAEs)
Secondary
· 3 years
The number of patients reporting treatment emergent adverse events (TEAEs) defined as an AE that occurs or worsens in the period extending from the first dose of study drug to 30 days after the last dose of study drug in this study
| Group | Value | 95% CI |
|---|---|---|
| Treatment | 8 |
Duration of Response
Secondary
· 3 years
Duration of response (DoR), defined as time from documentation of tumor response to disease progression
| Group | Value | 95% CI |
|---|---|---|
| Treatment | 62 | ± 0 |
Adverse events — posted to ClinicalTrials.gov
Time frame: 3 years. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Treatment
Serious: 6/8 (75%)
Deaths: 1/8
Serious adverse events (10 terms)
| Reaction | System | Treatment |
|---|---|---|
| Creatinine Increased | Investigations | — |
| Anemia | Blood and lymphatic system disorders | — |
| Sepsis | Infections and infestations | — |
| Pain | General disorders | — |
| Infections and Infestations - Other, Abscess | Infections and infestations | — |
| Kidney Infection | Infections and infestations | — |
| Platelet Count Decreased | Investigations | — |
| Hematuria | Renal and urinary disorders | — |
| Stroke | Vascular disorders | — |
| Urinary Tract Infection | Infections and infestations | — |
Other adverse events (54 terms — click to expand)
| Reaction | System | Treatment |
|---|---|---|
| Anemia | Blood and lymphatic system disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Fatigue | General disorders | — |
| Urinary Tract Infection | Infections and infestations | — |
| Hypomagnesemia | Metabolism and nutrition disorders | — |
| Gastroesophageal Reflux Disease | Gastrointestinal disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Creatinine Increased | Investigations | — |
| Platelet Count Decreased | Investigations | — |
| Anorexia | Metabolism and nutrition disorders | — |
| Hypokalemia | Metabolism and nutrition disorders | — |
| Hyponatremia | Metabolism and nutrition disorders | — |
| Back Pain | Musculoskeletal and connective tissue disorders | — |
| Hematuria | Renal and urinary disorders | — |
| Urinary Tract Obstruction | Renal and urinary disorders | — |
| Abdominal Pain | Gastrointestinal disorders | — |
| Constipation | Gastrointestinal disorders | — |
| Aspartate Aminotransferase Increased | Investigations | — |
| Hyperglycemia | Metabolism and nutrition disorders | — |
| Hyperuricemia | Metabolism and nutrition disorders | — |
| Hypoalbuminemia | Metabolism and nutrition disorders | — |
| Hypophosphatemia | Metabolism and nutrition disorders | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — |
| Flank Pain | Musculoskeletal and connective tissue disorders | — |
| Dizziness | Nervous system disorders | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — |
| Leukocytosis | Blood and lymphatic system disorders | — |
| Blurred Vision | Eye disorders | — |
| Colonic Obstruction | Gastrointestinal disorders | — |
| Gastrointestinal Disorders - Other, Hematochezia | Gastrointestinal disorders | — |
| Rectal Ulcer | Gastrointestinal disorders | — |
| Chills | General disorders | — |
| Pain | General disorders | — |
| Kidney Infection | Infections and infestations | — |
| Sepsis | Infections and infestations | — |
| Skin Infection | Infections and infestations | — |
| Fall | Injury, poisoning and procedural complications | — |
| Neutrophil Count Decreased | Investigations | — |
| Thyroid Stimulating Hormone Increased | Investigations | — |
| Dehydration | Metabolism and nutrition disorders | — |
Most-reported serious reactions: Creatinine Increased, Anemia, Sepsis, Pain, Infections and Infestations - Other, Abscess, Kidney Infection, Platelet Count Decreased, Hematuria.
Data from ClinicalTrials.gov NCT04483544 adverse events section.
Sponsor's own description
The study is a non-randomized, open-label phase II clinical trial to test the investigational combination of the drug pembrolizumab with the drug olaparib in patients diagnosed with advanced or recurrent cervical carcinoma after standard chemotherapy.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
WEE1 inhibition enhances the antitumor immune response to PD-L1 blockade by the concomitant activation of STING and STAT1 pathways in SCLC.
Taniguchi H, Caeser R, Chavan SS, Zhan YA, et al · · 2022 · cited 91× · PMID 35584676 · DOI 10.1016/j.celrep.2022.110814 -
Targeting DNA repair pathway in cancer: Mechanisms and clinical application.
Wang M, Chen S, Ao D. · · 2021 · cited 84× · PMID 34977872 · DOI 10.1002/mco2.103 -
The role of DNA damage repair (DDR) system in response to immune checkpoint inhibitor (ICI) therapy.
Shi C, Qin K, Lin A, Jiang A, et al · · 2022 · cited 60× · PMID 36071479 · DOI 10.1186/s13046-022-02469-0 -
PARP inhibitors as single agents and in combination therapy: the most promising treatment strategies in clinical trials for BRCA-mutant ovarian and triple-negative breast cancers.
Luo L, Keyomarsi K. · · 2022 · cited 56× · PMID 35435784 · DOI 10.1080/13543784.2022.2067527 -
Anti-cancer immune responses to DNA damage response inhibitors: Molecular mechanisms and progress toward clinical translation.
Carlsen L, El-Deiry WS. · · 2022 · cited 28× · PMID 36276148 · DOI 10.3389/fonc.2022.998388 -
The potential of PARP inhibitors in targeted cancer therapy and immunotherapy.
Hunia J, Gawalski K, Szredzka A, Suskiewicz MJ, et al · · 2022 · cited 25× · PMID 36533080 · DOI 10.3389/fmolb.2022.1073797 -
The Role of Immunotherapy in the Treatment of Advanced Cervical Cancer: Current Status and Future Perspectives.
Walsh RJ, Tan DSP. · · 2021 · cited 21× · PMID 34640541 · DOI 10.3390/jcm10194523 -
The anti-PD-1 era of cervical cancer: achievement, opportunity, and challenge.
Li C, Cang W, Gu Y, Chen L, et al · · 2023 · cited 19× · PMID 37559727 · DOI 10.3389/fimmu.2023.1195476
Verify or expand the search:
- PubMed search for NCT04483544
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Baptist Health South Florida trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT04483544 (US National Library of Medicine, public domain)
- 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 Baptist Health South Florida
- Last refreshed: 29 April 2025
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/NCT04483544.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing