Last reviewed · How we verify

NCT02834975

Pembrolizumab, Paclitaxel, and Carboplatin in Patients With Advanced Stage Epithelial Ovarian Cancer (EOC).

Terminated Phase 2 Results posted Last updated 7 November 2023
What this trial tests

Phase 2 trial testing Pembrolizumab in Fallopian Tube Cancer in 26 participants. Terminated before completion.

Timeline
22 December 2016
Primary endpoint
1 September 2022
1 December 2022

Quick facts

Lead sponsorUniversity of Miami
PhasePhase 2
StatusTerminated
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment26
Start date22 December 2016
Primary completion1 September 2022
Estimated completion1 December 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Miami

Who can join

18 and older, female only, with Fallopian Tube Cancer or Peritoneum Cancer. 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.

Pathologic Objective Response Rate (pORR) in Participants Receiving Protocol Therapy Primary · Up to 48 months

The pORR will be calculated as the percentage of participants with pathologic complete response (pCR) and pathologic partial response (pPR) overall as best response. For this protocol, pathologic complete response (pCR) will be defined as no residual macroscopic or (viable) microscopic disease. Pathologic partial response (pPR) will be defined as the presence of residual (viable) microscopic tumor, and the size of the largest focus will be provided for possible outcome correlation.

GroupValue95% CI
Pembrolizumab, Paclitaxel + Carboplatin6038.7 – 78.9
Progression-Free Survival (PFS) Secondary · Up to 48 months

Progression-Free Survival (PFS) is measured from date of start of treatment to the earliest occurrence of any of the following events: documented disease progression or death from any cause. Patients who are alive and progression-free will be censored at the date of last documented progression-free status which is the date of last tumor assessment according to RECIST v1.1.

GroupValue95% CI
Pembrolizumab, Paclitaxel + Carboplatin22.511.9 – NA
Number of Participants Experiencing Treatment-related Toxicity Secondary · Up to 48 Months

Safety and tolerability of the intervention will be reported as the number of participants experiencing treatment-related toxicity including serious adverse events (SAEs) and adverse events (AEs), as assessed by treating physician. Toxicity will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.0, per physician discretion.

All Treatment-related SAEs
GroupValue95% CI
Pembrolizumab, Paclitaxel + Carboplatin3
Grade 3 or higher treatment-related SAEs
GroupValue95% CI
Pembrolizumab, Paclitaxel + Carboplatin1
All Treatment-related AEs (excluding SAEs)
GroupValue95% CI
Pembrolizumab, Paclitaxel + Carboplatin23
Grade 3 or higher treatment-related AEs (excluding SAEs)
GroupValue95% CI
Pembrolizumab, Paclitaxel + Carboplatin10

Adverse events — posted to ClinicalTrials.gov

Time frame: 48 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Pembrolizumab, Paclitaxel + Carboplatin
Serious: 6/26 (23%)
Deaths: 11/26

Serious adverse events (8 terms)

ReactionSystemPembrolizumab, Paclitaxel …
Non-cardiac chest painGeneral disorders
Immune system disorder, otherImmune system disorders
Alanine aminotransferase increasedInvestigations
Aspartate aminotransferase increasedInvestigations
HeadacheNervous system disorders
DehydrationMetabolism and nutrition disorders
Urinary incontinenceRenal and urinary disorders
Urinary tract infectionRenal and urinary disorders
Other adverse events (83 terms — click to expand)

ReactionSystemPembrolizumab, Paclitaxel …
FatigueGeneral disorders
NauseaGastrointestinal disorders
Neutrophil count decreasedInvestigations
Peripheral sensory neuropathyNervous system disorders
AnemiaBlood and lymphatic system disorders
DiarrheaGastrointestinal disorders
Rash maculo-papularSkin and subcutaneous tissue disorders
ConstipationGastrointestinal disorders
Abdominal painGastrointestinal disorders
ArthralgiaMusculoskeletal and connective tissue disorders
Peripheral motor neuropathyNervous system disorders
Bone painMusculoskeletal and connective tissue disorders
AlopeciaSkin and subcutaneous tissue disorders
PruritusSkin and subcutaneous tissue disorders
Platelet count decreasedInvestigations
Back painMusculoskeletal and connective tissue disorders
Atrial fibrillationCardiac disorders
BloatingGastrointestinal disorders
Gastroesophageal reflux diseaseGastrointestinal disorders
VomitingGastrointestinal disorders
Edema limbsGeneral disorders
AnorexiaInvestigations
HyperglycemiaInvestigations
DizzinessNervous system disorders
DysgeusiaNervous system disorders
HeadacheNervous system disorders
Hot flashesVascular disorders
Sinus tachycardiaCardiac disorders
HyperthyroidismEndocrine disorders
Mucositis oralGastrointestinal disorders
FeverGeneral disorders
Flu like symptomsGeneral disorders
Wound complicationInjury, poisoning and procedural complications
Alanine aminotransferase increasedInvestigations
Aspartate aminotransferase increasedInvestigations
White blood cell decreasedInvestigations
StrokeNervous system disorders
InsomniaPsychiatric disorders
Urinary frequencyRenal and urinary disorders
Thromboembolic eventVascular disorders

Most-reported serious reactions: Non-cardiac chest pain, Immune system disorder, other, Alanine aminotransferase increased, Aspartate aminotransferase increased, Headache, Dehydration, Urinary incontinence, Urinary tract infection.

Data from ClinicalTrials.gov NCT02834975 adverse events section.

Sponsor's own description

The investigators hypothesize that tumor cell killing by cytotoxic chemotherapy exposes the immune system to high levels of tumor antigens.The combination of Paclitaxel/Carboplatin and Pembrolizumab may result in deeper and more durable responses compared with standard chemotherapy alone.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Targeted therapies in gynecological cancers: a comprehensive review of clinical evidence.
    Wang Q, Peng H, Qi X, Wu M, et al · · 2020 · cited 114× · PMID 32728057 · DOI 10.1038/s41392-020-0199-6
  2. Ovarian Cancer in the Era of Immune Checkpoint Inhibitors: State of the Art and Future Perspectives.
    Maiorano BA, Maiorano MFP, Lorusso D, Maiello E. · · 2021 · cited 60× · PMID 34503248 · DOI 10.3390/cancers13174438
  3. Immunotherapy in Gynecologic Cancers: Are We There Yet?
    Pakish JB, Jazaeri AA. · · 2017 · cited 39× · PMID 28840453 · DOI 10.1007/s11864-017-0504-y
  4. Current Possibilities of Gynecologic Cancer Treatment with the Use of Immune Checkpoint Inhibitors.
    Grywalska E, Sobstyl M, Putowski L, Roliński J. · · 2019 · cited 35× · PMID 31547532 · DOI 10.3390/ijms20194705
  5. Combination therapy with PD-1/PD-L1 blockade: An overview of ongoing clinical trials.
    Johnson CB, Win SY. · · 2018 · cited 26× · PMID 29632719 · DOI 10.1080/2162402x.2017.1408744
  6. Neoadjuvant treatment in ovarian cancer: New perspectives, new challenges.
    Nikolaidi A, Fountzilas E, Fostira F, Psyrri A, et al · · 2022 · cited 21× · PMID 35957909 · DOI 10.3389/fonc.2022.820128
  7. The Perfect Combination: Enhancing Patient Response to PD-1-Based Therapies in Epithelial Ovarian Cancer.
    James NE, Woodman M, DiSilvestro PA, Ribeiro JR. · · 2020 · cited 14× · PMID 32756436 · DOI 10.3390/cancers12082150
  8. Effectiveness and safety of nab-paclitaxel and platinum as first-line chemotherapy for ovarian cancer: a retrospective study.
    Wang L, Li S, Zhu D, Qin Y, et al · · 2023 · cited 6× · PMID 36807747 · DOI 10.3802/jgo.2023.34.e44

Verify or expand the search:

Other trials of Pembrolizumab

Trials testing the same drug.

Other recruiting trials for Fallopian Tube Cancer

Currently open trials in the same condition.

Other University of Miami trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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/NCT02834975.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing