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Anti-tumor antibiotic

Immunotherapy + Chemotherapy for Cervical Cancer

Phase 3
Waitlist Available
Research Sponsored by Merck Sharp & Dohme Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has persistent, recurrent, or metastatic squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix which has not been treated with systemic chemotherapy and is not amenable to curative treatment (such as with surgery and/or radiation).
Has measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 46 months
Awards & highlights

Study Summary

This trial is testing whether the immunotherapy drug pembrolizumab, when combined with standard chemotherapy, is more effective at treating cervical cancer than chemotherapy alone. The study will also look at the safety of the two treatments.

Who is the study for?
This trial is for adult women with persistent, recurrent, or metastatic cervical cancer who haven't had systemic chemotherapy and can't be cured by surgery/radiation. They must have measurable disease, not be pregnant/breastfeeding, use effective contraception if of childbearing potential, have a performance status of 0-1 indicating they are fully active or restricted in physically strenuous activity but ambulatory, and adequate organ function.Check my eligibility
What is being tested?
The study tests the effectiveness and safety of pembrolizumab (an immunotherapy drug) combined with platinum-based chemotherapy versus placebo plus chemotherapy. The goal is to see if pembrolizumab improves progression-free survival (time during and after treatment that the patient lives without the cancer getting worse) and overall survival compared to just chemotherapy.See study design
What are the potential side effects?
Pembrolizumab may cause immune system-related side effects such as inflammation in various organs like lungs (pneumonitis), liver problems, skin reactions, hormone gland issues (like thyroid disorders), infusion reactions; also fatigue and allergic reactions. Chemotherapy can cause hair loss, nausea/vomiting, increased risk of infection due to low blood cell counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cervical cancer cannot be cured with surgery or radiation and hasn't been treated with chemotherapy.
Select...
My cancer can be measured by scans.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I have mild nerve pain or hair loss.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 46 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 46 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
OS in All Participants
OS in Participants With PD-L1 CPS ≥10
Overall Survival (OS) in Participants With PD-L1 CPS ≥1
+3 more
Secondary outcome measures
Duration of Response (DOR) Per RECIST 1.1 as Assessed by Investigator
Number of Participants Who Discontinued Study Treatment Due to an AE
Number of Participants Who Experienced a Serious AE (SAE)
+6 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Activated partial thromboplastin time prolonged
5%
Intractable pain, back pain, hip pain
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Skin rash
2%
Thrombocytopenia
2%
Respiratory failure
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Pembrolizumab+ChemotherapyExperimental Treatment5 Interventions
On Day 1 of each 21-day cycle, participants receive an intravenous (IV) infusion of pembrolizumab 200 mg for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m^2 PLUS cisplatin 50 mg/m^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m^2 PLUS carboplatin Area Under the Curve (AUC) 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments are administered until disease progression or toxicity.
Group II: Placebo+ChemotherapyPlacebo Group5 Interventions
On Day 1 of each 21-day cycle, participants receive an IV infusion of placebo (Normal Saline or Dextrose solution) for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m^2 PLUS cisplatin 50 mg/m^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m^2 PLUS carboplatin AUC 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments are administered until disease progression or toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
2011
Completed Phase 4
~5380
Carboplatin
2014
Completed Phase 3
~6670
Pembrolizumab
2017
Completed Phase 2
~1950
Cisplatin
2013
Completed Phase 3
~1940
Bevacizumab
2013
Completed Phase 4
~5280

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,294 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,862 Previous Clinical Trials
5,049,083 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,769 Previous Clinical Trials
8,061,583 Total Patients Enrolled

Media Library

Carboplatin (Anti-tumor antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT03635567 — Phase 3
Cervical Cancer Research Study Groups: Pembrolizumab+Chemotherapy, Placebo+Chemotherapy
Cervical Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT03635567 — Phase 3
Carboplatin (Anti-tumor antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03635567 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the primary conditions that Pembrolizumab is used to treat?

"Pembrolizumab is used to fight disease and can be effective in treating hodgkin disease, metastatic cutaneous squamous cell carcinoma, and melanoma."

Answered by AI

Are there any current openings for volunteers in this clinical research?

"This study is not currently recruiting patients. The clinical trial was first posted on October 25th, 2018 and updated as recently as October 19th, 2022. There are 410 other trials searching for participants with uterine cervical neoplasms and 2673 studies for Pembrolizumab actively enrolling participants."

Answered by AI

What other medical research has been conducted with Pembrolizumab?

"Pembrolizumab's origins can be traced back to City of Hope Comprehensive Cancer Center in 1997. Since then, there have been 3253 completed trials and 2673 active ones. Many of the latter are based out of Orange, California."

Answered by AI

What are the researchers hoping to achieve with this clinical trial?

"According to the sponsor of this clinical trial, Merck Sharp & Dohme Corp., the primary outcome being measured over a period of up to approximately 2 years is progression-free survival (PFS) per response evaluation criteria in solid tumors version 1.1 (RECIST 1.1) as assessed by an investigator. In addition to the primary outcome, this study will be assessing secondary outcomes including the number of participants who experience an immune-related adverse event (irAE). An irAE is defined as an AE that may occur shortly after the first dose or several months after the last dose of pembrolizumab"

Answered by AI

How many different medical clinics are conducting this study?

"Currently, there are a total of 35 clinical trial sites recruiting for this study. In North America, these locations include UC Irvine Health ( Site 1796) in Orange, H. Lee Moffitt Cancer Center and Research Institute ( Site 1754) in Tampa, and CIUSSS du Saguenay-Lac-St-Jean ( Site 1729) in Chicoutimi."

Answered by AI

Is Pembrolizumab generally well-tolerated by patients?

"Pembrolizumab has received a score of 3 for safety. This is because it is in Phase 3, which suggests that there is efficacy data as well as multiple rounds of safety data."

Answered by AI

How many individuals are being asked to participate in this research project?

"At this time, individuals cannot join this trial as it is not recruiting patients. Although, this study was first posted on October 25th 2018 and updated recently on October 19th 2020. If you are interested in participating in other trials, there are 410 clinical trials for uterine cervical neoplasms and 2673 studies involving Pembrolizumab that are currently admitting participants."

Answered by AI
Recent research and studies
~96 spots leftby Mar 2025