Cervical CancerPhase 1NCT04551950
Bintrafusp Alfa Combination Therapy in Participants With Cervical Cancer (INTR@PID 046)
A Phase 1 study testing M7824, Carboplatin and Paclitaxel in people with Cervical Cancer, run by EMD Serono Research & Development Institute, Inc. at 13 sites in 3 countries.
Trial summary
This study was to evaluate the safety and tolerability of bintrafusp alfa in combination with other anti-cancer therapies in participants with locally advanced or advanced cervical cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- M7824, Carboplatin and Paclitaxel
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 13 sitesin 3 countries
- Study dates
- 19 Oct 2020to 30 Jun 2022
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inclusion Criteria for participants enrolling into Cohort 1:
- Study participants had documented persistent, recurrent, or metastatic squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix
- Study participants had not been treated with systemic chemotherapy and were not amenable to curative treatment
- Prior radiation with or without radio-sensitizing chemotherapy was allowed
- Inclusion Criteria for participants enrolling into Cohort 2:
- Participants had documented evidence of cervical adenocarcinoma, squamous cell carcinoma, or adenosquamous carcinoma International Federation of Gynecology and Obstetrics (FIGO) 2018 Stages 1B2 to 4A
Show all 14Show fewer
- Participants had not received prior chemotherapy or radiotherapy for cervical cancer
- Archival tumor tissue sample or newly obtained core or excisional biopsy was required
- Participants who had Eastern Cooperative Oncology Group (ECOG) Performance status (PS) of 0 to 1 were eligible
- Participants had a life expectancy greater than or equal to 12 weeks
- Participants had adequate hematological, hepatic, renal, and coagulation function as defined in the protocol
- Participants with known Human immunodeficiency virus (HIV) infections were eligible if the criteria described in the protocol were met
- Participants with Hepatitis B virus (HBV) and/or Hepatitis C virus (HCV) infections were eligible if the criteria described in the protocol were met
- Other protocol defined inclusion criteria could apply
Who cannot join
- Participants with active central nervous system (CNS) metastases causing clinical symptoms or metastases that required therapeutic intervention were excluded. Participants with a history of treated CNS metastases (by surgery or radiation therapy) were not eligible unless they had fully recovered from treatment, demonstrated no progression for at least 4 weeks, and were not using steroids for at least 7 days prior to the start of study intervention
- Participants that received any organ transplantation, including allogeneic stem-cell transplantation, but with the exception of transplants that did not require immuno-suppression
- Participants with significant acute or chronic infections
- Participants with active autoimmune disease that might have deteriorated when receiving an immuno-stimulatory agent
- Participants with clinically significant cardiovascular/cerebrovascular disease including: a cerebral vascular accident/stroke, myocardial infarction, unstable angina, congestive heart failure, or serious cardiac arrhythmia
- Participants with a history of bleeding diathesis or recent major bleeding events
Show all 20Show fewer
- Participant that had received prior cancer treatment with any other immunotherapy or checkpoint inhibitors or any other immune-modulating monoclonal antibody (mAb)
- Exclusion Criteria for Participants in Cohort 1A related to use of bevacizumab were:
- Participants with inadequately controlled hypertension
- Prior history of hypertensive crisis or hypertensive encephalopathy
- Participants with significant vascular disease within 6 months prior to Screening
- Participants with a history of hemoptysis within 1 month prior to Screening
- Current use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic purposes
- Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to the first dose of bevacizumab
- Participants with a history of abdominal or trache-oesophageal fistula or gastrointestinal (GI) perforation within 6 months prior to Screening
- Participants with clinical signs of GI obstruction or requirement for routine parenteral hydration, parenteral nutrition, or tube feeding
- Participants with evidence of abdominal free air not explained by paracentesis or recent surgical procedure
- Participants with serious, non-healing wound, active ulcer, or untreated bone fracture
- Participants with proteinuria
- Other protocol defined exclusion criteria could apply
Trial locations and contacts
13 sites in 3 countries.
13 sites in 3 countries
United States5 sites
Augusta University - formerly Georgia Regents University
Augusta, Georgia, 30912
University of Cincinnati Physicians Group, LLC - Pharmatech Oncology, Inc
Cincinnati, Ohio, 45206
UT Southwestern Medical Center
Dallas, Texas, 75390
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, 89074
Stanford Health Care Hospital & Clinics
Stanford, California, 94305
Japan5 sites
National Cancer Center Hospital
Chūōku
Saitama Medical University International Medical Center
Hidaka-shi
Cancer Institute Hospital of JFCR
Kōtoku
Osaka International Cancer Institute
Osaka
Shizuoka Cancer Center
Sunto-gun
Spain3 sites
Hospital Clinic i Provincial de Barcelona - Servicio de Oncologia
Barcelona
Hospital Universitari Vall d'Hebron - Dept of Oncology
Barcelona
ICO l´Hospitalet - Hospital Duran i Reynals - Servicio de Oncologia
Barcelona
About this study
Official title: Safety Study of Bintrafusp Alfa in Combination With Other Anti-cancer Therapies in Participants With Locally Advanced or Advanced Cervical Cancer (INTR@PID 046)
This study was to evaluate the safety and tolerability of bintrafusp alfa in combination with other anti-cancer therapies in participants with locally advanced or advanced cervical cancer.
- Conditions
- Cervical Cancer
- Being tested
- M7824, Carboplatin, Paclitaxel, Bevacizumab, Cisplatin
- Keywords
- Advanced cervical cancer, Bintrafusp alfa, M7824, INTR@PID, Transforming growth factor-beta, Programmed death-ligand 1
- Medical subject headings
- Uterine Cervical Neoplasms, Camurati-Engelmann Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M7824Drug
Also called Bintrafusp alfa
Participants received bintrafusp alfa until confirmed disease progression, death, unacceptable toxicity and study withdrawal maximum of 2 years (at the discretion of the Investigator).
CarboplatinDrug
Carboplatin was administered intravenously as per standard of care.
PaclitaxelDrug
Paclitaxel was administered intravenously as per standard of care.
BevacizumabDrug
Bevacizumab was administrated as indicated for standard of care.
CisplatinDrug
Cisplatin was administered intravenously as per standard of care.
RadiotherapyRadiation
Participants received radiotherapy as per standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1A:M7824+Cisplatin/Carboplatin+Paclitaxel+Bevacizumab | Experimental | Not described Receives: Drug: M7824; Drug: Carboplatin; Drug: Paclitaxel; Drug: Bevacizumab; Drug: Cisplatin |
| Cohort1B:M7824+Cisplatin or Carboplatin+Paclitaxel | Experimental | Not described Receives: Drug: M7824; Drug: Carboplatin; Drug: Paclitaxel; Drug: Cisplatin |
| Cohort 2: M7824+Cisplatin+ Radiotherapy | Experimental | Not described Receives: Drug: M7824; Drug: Cisplatin; Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Dose-Limiting Toxicities (DLTs)
DLT was defined as Adverse Events (AEs) with any of following toxicities: Grade 4 nonhematologic toxicity or hematologic toxicity lasting more than equal to (>=) 7 days despite medical intervention; Grade 3 nausea, vomiting, and diarrhea lasting >= 3 days despite supportive care; Any Grade 3 or Grade 4 nonhematologic lab value leading to hospitalization or persisting for >= 7 days; Grade 3 or Grade 4: grade 3 is defined as absolute neutrophil count (ANC) less than (<) 1,000/mm3 with a temperature of > 38.3 degree Celsius (°C); grade 4 is defined as ANC < 1,000/mm3 with a temperature of > 38.3°C, with life-threatening consequences; Thrombocytopenia < 25,000/mm3 associated with bleeding not resulting in hemodynamic instability or a life-threatening bleeding resulting in urgent intervention; Bleeding events >= Grade 3 occurring within 5 days of bintrafusp alfa treatment; Prolonged delay (> 3 weeks) in initiating Cycle 2 due to treatment-related toxicity; Grade 5 toxicity.
Measured: Up to 4 weeks after first administration of study intervention
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Adverse Event (AE) was defined any untoward medical occurrence in a participant administered with a study drug, which does not necessarily had a causal relationship with this treatment. Treatment-Emergent Adverse Events (TEAEs) were defined as events with onset date or worsening during the on-treatment period. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAEs included serious TEAEs and non-serious TEAEs.
Measured: Time from first treatment assessed up to approximately 20 months
Secondary outcomes (10)
Immediate Observed Serum Concentration at End of Infusion (Ceoi) of Bintrafusp Alfa
Ceoi was the observed concentration at the end of the infusion period. This was taken directly from the observed Bintrafusp Alfa concentration-time data.
Measured: Pre-dose Up to 20 months
Serum Trough Concentration Levels (Ctrough) of Bintrafusp Alfa
Ctrough was the serum concentration observed immediately before next dosing.
Measured: Pre-dose Up to 20 months
Area Under the Serum Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of Bintrafusp Alfa
The area under the concentration-time curve (AUC) from time zero (= dosing time) to the last sampling time (tlast) at which the concentration is at or above the lower limit of quantification. Calculated using the mixed log-linear trapezoidal rule (linear up, log down).
Measured: Pre-dose Up to 20 months
Area Under the Serum Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Bintrafusp Alfa
AUC0-inf was calculated by combining AUC0-t and AUCextra. AUCextra represents an extrapolated value obtained by Clast pred/Lambda z, where Clast pred was the calculated serum concentration at the last sampling time point at which the measured serum concentration is at or above the Lower Limit of quantification (LLQ) and Lambda z was the apparent terminal rate constant determined by log-linear regression analysis of the measured serum concentrations of the terminal log-linear phase.
Measured: Pre-dose Up to 20 months
Maximum Observed Serum Concentration (Cmax) of Bintrafusp Alfa
Cmax was obtained directly from the concentration versus time curve.
Measured: Pre-dose Up to 20 months
Time to Reach Maximum Serum Concentration (Tmax) of Bintrafusp Alfa
The time to reach the maximum observed concentration collected during a dosing interval. Tmax was obtained directly from the concentration versus time curve.
Measured: Pre-dose Up to 20 months
Terminal Elimination Half-Life (T1/2) of Bintrafusp Alfa
Elimination Half Life (T1/2) was defined as the time required for the concentration or amount of drug in the body to be reduced by one-half. Elimination half-life determined as 0.693/ Lamda z(λz), λz=terminal first order (elimination) rate constant.
Measured: Pre-dose Up to 20 months
Number of Participants With Positive Anti-Drug Antibody (ADA) of Bintrafusp Alfa
A validated method was applied to detect ADAs in the presence of drug in human serum. The ADA titers of positive samples were determined.
Measured: Pre-dose Up to 20 months
Number of Japanese Participants With Dose-Limiting Toxicities (DLTs)
DLT was defined as Adverse Events (AEs) with any of following toxicities: Grade 4 nonhematologic toxicity or hematologic toxicity lasting more than equal to (>=) 7 days despite medical intervention; Grade 3 nausea, vomiting, and diarrhea lasting >= 3 days despite supportive care; Any Grade 3 or Grade 4 nonhematologic lab value leading to hospitalization or persisting for >= 7 days; Grade 3 or Grade 4: grade 3 is defined as absolute neutrophil count (ANC) less than (<) 1,000/mm3 with a temperature of > 38.3 degree Celsius (°C); grade 4 is defined as ANC < 1,000/mm3 with a temperature of > 38.3°C, with life-threatening consequences; Thrombocytopenia < 25,000/mm3 associated with bleeding not resulting in hemodynamic instability or a life-threatening bleeding resulting in urgent intervention; Bleeding events >= Grade 3 occurring within 5 days of bintrafusp alfa treatment; Prolonged delay (> 3 weeks) in initiating Cycle 2 due to treatment-related toxicity; Grade 5 toxicity.
Measured: Up to 4 weeks after first administration of study intervention
Number of Japanese Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Adverse Event (AE) was defined any untoward medical occurrence in a participant administered with a study drug, which does not necessarily had a causal relationship with this treatment. Treatment-Emergent Adverse Events (TEAEs) were defined as events with onset date or worsening during the on-treatment period. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important.
Measured: Time from first treatment assessed up to approximately 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start19 Oct 2020
- Primary completion15 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by EMD Serono Research & Development Institute, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck KGaA, Darmstadt, Germany
- Responsible party
- Sponsor
- Investigators
- Medical Responsible, Study director, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04551950
- Sponsor's protocol ID
- MS200647_0046
- Other IDs
- 2020-001561-36
- Status last verified
- Jul 2023
- First submitted
- 7 Sep 2020
- Last updated
- 8 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Per company policy, following approval of a new product or a new indication for an approved product in both the EU and the US, EMD Serono will share study protocols, anonymized patient level and study level data and redacted clinical study reports from clinical trials in patients with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website https://www.emdgroup.com/en/research/our-approach-to-research-and-development/healthcare/clinical-trials/commitment-responsible-data-sharing.html
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Study of Bintrafusp Alfa in Combination With Other Anti-cancer Therapies in Participants With Locally Advanced or Advanced Cervical Cancer (INTR@PID 046)
- ClinicalTrials.gov ID
- NCT04551950
- Acronym / sponsor ID
- MS200647_0046
- Conditions
- Cervical Cancer
- Keywords
- Advanced cervical cancer, Bintrafusp alfa, M7824, INTR@PID, Transforming growth factor-beta, Programmed death-ligand 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- EMD Serono Research & Development Institute, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Merck KGaA, Darmstadt, Germany
- Study start
- 19 Oct 2020 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 16 Sep 2020 (actual)
- Results
- Posted 8 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was to evaluate the safety and tolerability of bintrafusp alfa in combination with other anti-cancer therapies in participants with locally advanced or advanced cervical cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1A:M7824+Cisplatin/Carboplatin+Paclitaxel+Bevacizumab | Experimental | Drug: M7824, Drug: Carboplatin, Drug: Paclitaxel, Drug: Bevacizumab, Drug: Cisplatin |
| Cohort1B:M7824+Cisplatin or Carboplatin+Paclitaxel | Experimental | Drug: M7824, Drug: Carboplatin, Drug: Paclitaxel, Drug: Cisplatin |
| Cohort 2: M7824+Cisplatin+ Radiotherapy | Experimental | Drug: M7824, Drug: Cisplatin, Radiation: Radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Inclusion Criteria for participants enrolling into Cohort 1:
- Study participants had documented persistent, recurrent, or metastatic squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix
- Study participants had not been treated with systemic chemotherapy and were not amenable to curative treatment
- Prior radiation with or without radio-sensitizing chemotherapy was allowed
- Inclusion Criteria for participants enrolling into Cohort 2:
Key exclusion criteria (20 listed)
- Participants with active central nervous system (CNS) metastases causing clinical symptoms or metastases that required therapeutic intervention were excluded. Participants with a history of treated CNS metastases (by surgery or radiation therapy) were not eligible unless they had fully recovered from treatment, demonstrated no progression for at least 4 weeks, and were not using steroids for at least 7 days prior to the start of study intervention
- Participants that received any organ transplantation, including allogeneic stem-cell transplantation, but with the exception of transplants that did not require immuno-suppression
- Participants with significant acute or chronic infections
- Participants with active autoimmune disease that might have deteriorated when receiving an immuno-stimulatory agent
- Participants with clinically significant cardiovascular/cerebrovascular disease including: a cerebral vascular accident/stroke, myocardial infarction, unstable angina, congestive heart failure, or serious cardiac arrhythmia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| M7824Also: Bintrafusp alfaParticipants received bintrafusp alfa until confirmed disease progression, death, unacceptable toxicity and study withdrawal maximum of 2 years (at the discretion of the Investigator). | Drug | Cohort 1A:M7824+Cisplatin/Carboplatin+Paclitaxel+Bevacizumab, Cohort 2: M7824+Cisplatin+ Radiotherapy, Cohort1B:M7824+Cisplatin or Carboplatin+Paclitaxel |
| CarboplatinCarboplatin was administered intravenously as per standard of care. | Drug | Cohort 1A:M7824+Cisplatin/Carboplatin+Paclitaxel+Bevacizumab, Cohort1B:M7824+Cisplatin or Carboplatin+Paclitaxel |
| PaclitaxelPaclitaxel was administered intravenously as per standard of care. | Drug | Cohort 1A:M7824+Cisplatin/Carboplatin+Paclitaxel+Bevacizumab, Cohort1B:M7824+Cisplatin or Carboplatin+Paclitaxel |
| BevacizumabBevacizumab was administrated as indicated for standard of care. | Drug | Cohort 1A:M7824+Cisplatin/Carboplatin+Paclitaxel+Bevacizumab |
| CisplatinCisplatin was administered intravenously as per standard of care. | Drug | Cohort 1A:M7824+Cisplatin/Carboplatin+Paclitaxel+Bevacizumab, Cohort 2: M7824+Cisplatin+ Radiotherapy, Cohort1B:M7824+Cisplatin or Carboplatin+Paclitaxel |
| RadiotherapyParticipants received radiotherapy as per standard of care. | Radiation | Cohort 2: M7824+Cisplatin+ Radiotherapy |
Primary outcome
Number of Participants With Dose-Limiting Toxicities (DLTs)
Time frame: Up to 4 weeks after first administration of study intervention
DLT was defined as Adverse Events (AEs) with any of following toxicities: Grade 4 nonhematologic toxicity or hematologic toxicity lasting more than equal to (>=) 7 days despite medical intervention; Grade 3 nausea, vomiting, and diarrhea lasting >= 3 days despite supportive care; Any Grade 3 or Grade 4 nonhematologic lab value leading to hospitalization or persisting for >= 7 days; Grade 3 or Grade 4: grade 3 is defined as absolute neutrophil count (ANC) less than (<) 1,000/mm3 with a temperature of > 38.3 degree Celsius (°C); grade 4 is defined as ANC < 1,000/mm3 with a temperature of > 38.3°C, with life-threatening consequences; Thrombocytopenia < 25,000/mm3 associated with bleeding not resulting in hemodynamic instability or a life-threatening bleeding resulting in urgent intervention; Bleeding events >= Grade 3 occurring within 5 days of bintrafusp alfa treatment; Prolonged delay (> 3 weeks) in initiating Cycle 2 due to treatment-related toxicity; Grade 5 toxicity.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Time from first treatment assessed up to approximately 20 months
Adverse Event (AE) was defined any untoward medical occurrence in a participant administered with a study drug, which does not necessarily had a causal relationship with this treatment. Treatment-Emergent Adverse Events (TEAEs) were defined as events with onset date or worsening during the on-treatment period. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAEs included serious TEAEs and non-serious TEAEs.
10 secondary outcomes
Immediate Observed Serum Concentration at End of Infusion (Ceoi) of Bintrafusp Alfa
Time frame: Pre-dose Up to 20 months
Serum Trough Concentration Levels (Ctrough) of Bintrafusp Alfa
Time frame: Pre-dose Up to 20 months
Area Under the Serum Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of Bintrafusp Alfa
Time frame: Pre-dose Up to 20 months
Area Under the Serum Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Bintrafusp Alfa
Time frame: Pre-dose Up to 20 months
Maximum Observed Serum Concentration (Cmax) of Bintrafusp Alfa
Time frame: Pre-dose Up to 20 months
Time to Reach Maximum Serum Concentration (Tmax) of Bintrafusp Alfa
Time frame: Pre-dose Up to 20 months
Terminal Elimination Half-Life (T1/2) of Bintrafusp Alfa
Time frame: Pre-dose Up to 20 months
Number of Participants With Positive Anti-Drug Antibody (ADA) of Bintrafusp Alfa
Time frame: Pre-dose Up to 20 months
Number of Japanese Participants With Dose-Limiting Toxicities (DLTs)
Time frame: Up to 4 weeks after first administration of study intervention
Number of Japanese Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Time from first treatment assessed up to approximately 20 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Trial Awareness and Transparency websiteLink provided by the sponsor.
- US Medical Information website, Medical ResourcesLink provided by the sponsor.
- Individual participant dataSharing planned: No. Per company policy, following approval of a new product or a new indication for an approved product in both the EU and the US, EMD Serono will share study protocols, anonymized patient level and study level data and redacted clinical study reports from clinical trials in patients with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website https://www.emdgroup.com/en/research/our-approach-to-research-and-development/healthcare/clinical-trials/commitment-responsible-data-sharing.html
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Responsible study director
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
13 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing M7824, Carboplatin and Paclitaxel in people with Cervical Cancer, run by EMD Serono Research & Development Institute, Inc. at 13 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Japan, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Dose-Limiting Toxicities (DLTs) (time frame: Up to 4 weeks after first administration of study intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2024.