Endometrial CancerPhase 2NCT02549209
Pembro/Carbo/Taxol in Endometrial Cancer
A Phase 2 study testing Pembrolizumab, Paclitaxel and Carboplatin in people with Endometrial Cancer and Endometrial Adenocarcinoma, run by Daniela Matei, MD at 6 sites in United States.
Trial summary
This is a single-arm, open-label, multi-center phase II study for subjects with measurable advanced or recurrent endometrial cancer using pembrolizumab in combination with carboplatin and paclitaxel chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer, Endometrial Adenocarcinoma
- What is being tested?
- Pembrolizumab, Paclitaxel and Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 6 sitesUnited States
- Study dates
- 22 Aug 2017to 10 Feb 2022
- Phase
- Phase 2
- 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
- Written informed consent and HIPAA authorization for release of personal health information prior to registration for protocol therapy.
- o NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
- Age ≥ 18 years at the time of consent.
- ECOG Performance Status of 0 or 1 within 28 days prior to registration for protocol therapy.
- Histological evidence of newly diagnosed Stage III or IV or recurrent endometrial carcinoma who have had definitive surgery for endometrial cancer (at least hysterectomy and bilateral salpingo-oophorectomy). Pathologic documentation of the recurrence (i.e., biopsy) will be performed per standard of care, at the treating physician's discretion. If a subject with recurrence is undergoing a biopsy for clinical indications and is willing and able, an optional collection of 3 frozen tissue cores of the recurrence site is requested for correlative analysis.
- Measurable disease according to RECIST v1.1 and obtained by imaging within 28 days prior to registration for protocol therapy. Disease in an irradiated field as the only site of measurable disease is acceptable only if there has been clear progression since completion of radiation treatment.
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- The subject must have recovered (≤ grade 1) from the acute toxic effects of prior therapy.
- Prior treatment: Subjects may have received none or one platinum-based chemotherapy regimen and none or one non-platinum regimen. Subjects having received prior platinum-based chemotherapy must have a disease-free interval > 6 months (be platinum sensitive).
- Prior therapy with hormones or biologic agents is allowed. These treatments must be discontinued at least 28 days prior to registration for protocol therapy.
- The subject must have completed radiation therapy at least 28 days prior to registration for protocol therapy, provided that toxicity has resolved to ≤ grade 1.
- NOTES: Subjects may have received prior radiation therapy for treatment of endometrial carcinoma. Prior radiation therapy may have included pelvic radiation therapy, extended field pelvic/para-aortic radiation therapy, and/or intravaginal brachytherapy. Chemotherapy used for radiation sensitization is allowed. Chemotherapy used for radiation sensitization will not count as second chemotherapy regimen.
- Palliative radiation given primarily for symptom relief, without the intent to treat or cure the patient's endometrial cancer is excluded from the above criteria. Treatment-directed radiation will be defined as more than 30 Gy of radiation.
- No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the subject has been disease-free for at least 5 years.
- Female subjects must be of non-childbearing potential. Women of childbearing potential are those who have not been surgically sterilized or have not been free from menses for ≥1 year.
- Laboratory values must be obtained within 14 days prior to registration for protocol therapy. Note: Institutional/laboratory upper limit of normal (ULN)
- Hemoglobin (Hgb) > 9 g/dL (without transfusion or EPO dependency within 7 days of assessment)
- Platelets > 100 K/mm3
- Absolute neutrophil count (ANC) ≥ 1.5 K/mm3
- Creatinine or measured/calculated creatinine clearance (as calculated by institutional standard) ≤ 1.5 X institutional ULN OR ≥60mL/min for subjects with creatinine levels > 1.5 x institutional ULN
- Serum total bilirubin ≤ 1.5 ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 ULN
- AST, ALT or alkaline phosphatase < 2.5 ULN OR ≤ 5 x ULN for subjects with liver metastases
- Albumin ≥ 2.5 mg/dL
- International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 x ULN unless subject is receiving anti-coagulant therapy as long as PTT is within therapeutic range of intended use of anticoagulants
- Activated Partial Thromboplastin Time (aPTT) ≤ 1.5 x ULN unless subject is receiving anti-coagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
Who cannot join
- Subjects with carcinosarcoma.
- Subjects who have a solitary central pelvic recurrence, which can be curatively resected.
- Hypersensitivity to pembrolizumab or any of its excipients.
- Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to registration for protocol therapy or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to registration for protocol therapy and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior registration for protocol therapy. This exception does not include carcinomatous meningitis, which is excluded regardless of clinical stability.
- NOTE: Subjects with neurological symptoms must undergo a head CT scan or brain MRI to exclude brain metastasis.
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- Treatment with any investigational agent within 28 days prior to registration for protocol therapy.
- Has known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
- Active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- Has received systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to registration for protocol therapy. (Prednisone (or equivalent) < 10mg/ day is allowed).
- Has a known history of active TB (Bacillus Tuberculosis).
- Pulmonary conditions such as sarcoidosis, silicosis, idiopathic pulmonary fibrosis, or hypersensitivity pneumonitis.
- Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
- Evidence of interstitial lung disease.
- Has an active infection requiring systemic therapy with the exception of an uncomplicated urinary tract infection.
- Pre-existing peripheral neuropathy that is ≥ Grade 2 by CTCAE v4 criteria.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
- Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority.
- Has received a live vaccine within 30 days prior to registration for protocol therapy.
- o NOTE: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however, intranasal influenza vaccines (e.g., Flu-Mist) are live attenuated vaccines, and are not allowed.
- History of solid organ or stem cell transplant requiring immunosuppressive medications.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Northwestern University, Robert H. Lurie Cancer Center
Chicago, Illinois, 60611
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois, 60045
Ironwood Cancer and Research Centers
Mesa, Arizona, 85206
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Phase II Study of Pembrolizumab in Combination With Carboplatin and Paclitaxel for Advanced or Recurrent Endometrial Adenocarcinoma
This is a single-arm, open-label, multi-center phase II study for subjects with measurable advanced or recurrent endometrial cancer using pembrolizumab in combination with carboplatin and paclitaxel chemotherapy. As this combination of agents has not been tested in this subject population, the first six subjects enrolled will constitute a safety run-in cohort.
Read the detailed description
OUTLINE: This is a multi-center study.
INVESTIGATIONAL TREATMENT:
To ensure the safety of this combination treatment, an initial safety run-in will be conducted for the first 6 subjects. This initial cohort of 6 subjects will be enrolled and treated with standard doses as described below. Based on toxicity analysis of the initial 6 subjects following completion of 18 weeks of treatment, it will be determined if an extended safety run-in period would be beneficial.
In the absence of receiving any prior therapy, eligible subjects will be treated as follows on D1 of cycles lasting 21 days (3 weeks) for a maximum of 6 cycles:
- Pembrolizumab 200mg will be administered as a 30-minute intravenous (IV) infusion every 3 weeks.
- Paclitaxel will be dosed at 175mg/m2 and be administered as a 3-hour continuous IV infusion.
- Carboplatin will be dosed at area under the curve (AUC) of 6 and given as an IV infusion in 250ml of D5W over 30 minutes.
Subjects who have had prior radiotherapy/platinum-based chemotherapy must initiate paclitaxel and carboplatin at the following reduced dose levels if they have had prior external radiotherapy involving the whole pelvis or abdomen or over 50% of their spine, and/or prior platinum-based chemotherapy for this, or any other cancer. Eligible subjects will be treated as follows on Day 1 (D1) of cycles lasting 21 days (3 weeks) for a maximum of 6 cycles:
- Pembrolizumab 200mg administered as a 30-minute intravenous (IV) infusion every 3 weeks.
- Paclitaxel will be dosed at 135mg/m2 and be administered as a 3-hour continuous IV infusion.
- Carboplatin will be dosed at an AUC of 5 and given as an IV infusion in 250ml of D5W over 30 minutes.
Subsequent doses of paclitaxel and carboplatin may be escalated to the higher doses as indicated above, provided these subjects do not exhibit hematologic or nonhematologic toxicity > Grade 1, except alopecia.
The following laboratory values must be obtained within 14 days prior to registration for protocol therapy:
Hematopoietic:
- Hemoglobin (Hgb) > 9 g/dL (without transfusion or erythropoietin (EPO) dependency within 7 days of assessment)
- Platelets > 100 K/mm3
- Absolute neutrophil count (ANC) ≥ 1.5 K/mm3
Renal:
- Creatinine or measured/calculated creatinine clearance (as calculated by institutional standard) ≤ 1.5 X institutional upper limits of normal (ULN) OR ≥60mL/min for subjects with creatinine levels > 1.5 x institutional ULN
Hepatic:
- Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) OR direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 ULN
- Aspartate aminotransferase (AST), alanine transaminase (ALT) or alkaline phosphatase (ALP) < 2.5 x ULN OR ≤ 5 x ULN for subjects with liver metastases
- Albumin ≥ 2.5 mg/dL
Coagulation (Blood Clotting) Tests:
- International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 x ULN unless subject is receiving anti-coagulant therapy as long as partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
- Activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN unless subject is receiving anti-coagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
- Conditions
- Endometrial Cancer, Endometrial Adenocarcinoma
- Being tested
- Pembrolizumab, Paclitaxel, Carboplatin
- Keywords
- Pembrolizumab, Keytruda, Anti-Programmed [Cell] Death Protein 1 (PD-1) Antibody, Carboplatin, Paclitaxel
- Medical subject headings
- Endometrial Neoplasms, Parkinson Disease 4, Autosomal Dominant Lewy Body
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
Also called MK-3475, Keytruda®
Pembrolizumab 200 mg will be administered every 3 weeks for all subjects
PaclitaxelDrug
Also called Taxol®
For subjects with no prior therapy, paclitaxel will be dosed at 175mg/m2 and be administered as a 3-hour continuous IV infusion.
Subjects with prior XRT/platinum-based chemotherapy must initiate paclitaxel at 135mg/m2 and be administered as a 3-hour continuous IV infusion.
CarboplatinDrug
Also called Paraplatin®
For subjects with no prior therapy, carboplatin will be dosed at an AUC of 6 and given as an IV infusion in 250ml of D5W over 30 minutes.
Subjects with prior XRT/platinum-based chemotherapy must initiate carboplatin at an AUC of 5 given as an IV infusion in 250ml of D5W over 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Investigational Treatment | Experimental | Subjects with no prior therapy:
* Pembrolizumab administered at 200 mg
* Paclitaxel administered at 175mg/m2
* Carboplatin administered at an AUC of 6
Subjects with prior external beam radiation therapy (XRT) and/or platinum-based chemotherapy must initiate paclitaxel and carboplatin at a reduced dose:
* Pembrolizumab administered at 200 mg
* Paclitaxel administered at 135mg/m2
* Carboplatin administered at an AUC of 5 Receives: Drug: Pembrolizumab; Drug: Paclitaxel; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rates (ORR)
Objective response rate(ORR) is defined as the percentage of subjects with a partial response or complete response according to immune-related RECIST criteria.
Immune-Related Response Criteria:
Complete Response(irCR): Disappearance of all lesions in two consecutive observations not less than 4 wk apart.
Partial Reponse (irPR): decrease in tumor burden ≥50 %relative to baseline confirmed by a consecutive assessment at least 4 wk after first documentation Stable Disease (irSD): not meeting criteria for irCR or irPR, in absence of irPD
Measured: From start of treatment Day 1 (D1) and assessed for a maximum of 18 months
Secondary outcomes (1)
Proportion of Subjects Who Experience ≥ Grade 3 Toxicity According Per Common Toxicity Criteria for Adverse Effects (CTCAE) v4 Criteria
Proportion of subjects who experience ≥ Grade 3 toxicity regardless of relation according per Common Toxicity Criteria for Adverse Effects (CTCAE) v4 criteria while receiving pembrolizumab in combination with standard carboplatin/paclitaxel therapy
Measured: From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2015 (estimated)
- Study start22 Aug 2017
- Primary completion12 Dec 2019
- Study completion10 Feb 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 Endometrial CancerStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daniela Matei, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Hoosier Cancer Research Network
- Responsible party
- Sponsor-investigator, Daniela Matei, MD, Big Ten Cancer Research Consortium
- Investigators
- Daniela Matei, M.D., Study chair, Big Ten Cancer Research Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02549209
- Sponsor's protocol ID
- BTCRC GYN15-013
- Status last verified
- Feb 2022
- First submitted
- 11 Sep 2015
- Last updated
- 2 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Pembrolizumab in Combination With Carboplatin and Paclitaxel for Advanced or Recurrent Endometrial Adenocarcinoma
- ClinicalTrials.gov ID
- NCT02549209
- Acronym / sponsor ID
- BTCRC GYN15-013
- Conditions
- Endometrial Cancer, Endometrial Adenocarcinoma
- Keywords
- Pembrolizumab, Keytruda, Anti-Programmed [Cell] Death Protein 1 (PD-1) Antibody, Carboplatin, Paclitaxel
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Daniela Matei, MDUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Hoosier Cancer Research Network
- Study start
- 22 Aug 2017 (actual)
- Primary completion
- 12 Dec 2019 (actual)
- Study completion
- 10 Feb 2022 (actual)
- First posted
- 15 Sep 2015 (estimated)
- Results
- Posted 30 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-arm, open-label, multi-center phase II study for subjects with measurable advanced or recurrent endometrial cancer using pembrolizumab in combination with carboplatin and paclitaxel chemotherapy. As this combination of agents has not been tested in this subject population, the first six subjects enrolled will constitute a safety run-in cohort.
Detailed description
OUTLINE: This is a multi-center study.
INVESTIGATIONAL TREATMENT:
To ensure the safety of this combination treatment, an initial safety run-in will be conducted for the first 6 subjects. This initial cohort of 6 subjects will be enrolled and treated with standard doses as described below. Based on toxicity analysis of the initial 6 subjects following completion of 18 weeks of treatment, it will be determined if an extended safety run-in period would be beneficial.
In the absence of receiving any prior therapy, eligible subjects will be treated as follows on D1 of cycles lasting 21 days (3 weeks) for a maximum of 6 cycles:
- Pembrolizumab 200mg will be administered as a 30-minute intravenous (IV) infusion every 3 weeks.
- Paclitaxel will be dosed at 175mg/m2 and be administered as a 3-hour continuous IV infusion.
- Carboplatin will be dosed at area under the curve (AUC) of 6 and given as an IV infusion in 250ml of D5W over 30 minutes.
Subjects who have had prior radiotherapy/platinum-based chemotherapy must initiate paclitaxel and carboplatin at the following reduced dose levels if they have had prior external radiotherapy involving the whole pelvis or abdomen or over 50% of their spine, and/or prior platinum-based chemotherapy for this, or any other cancer. Eligible subjects will be treated as follows on Day 1 (D1) of cycles lasting 21 days (3 weeks) for a maximum of 6 cycles:
- Pembrolizumab 200mg administered as a 30-minute intravenous (IV) infusion every 3 weeks.
- Paclitaxel will be dosed at 135mg/m2 and be administered as a 3-hour continuous IV infusion.
- Carboplatin will be dosed at an AUC of 5 and given as an IV infusion in 250ml of D5W over 30 minutes.
Subsequent doses of paclitaxel and carboplatin may be escalated to the higher doses as indicated above, provided these subjects do not exhibit hematologic or nonhematologic toxicity > Grade 1, except alopecia.
The following laboratory values must be obtained within 14 days prior to registration for protocol therapy:
Hematopoietic:
- Hemoglobin (Hgb) > 9 g/dL (without transfusion or erythropoietin (EPO) dependency within 7 days of assessment)
- Platelets > 100 K/mm3
- Absolute neutrophil count (ANC) ≥ 1.5 K/mm3
Renal:
- Creatinine or measured/calculated creatinine clearance (as calculated by institutional standard) ≤ 1.5 X institutional upper limits of normal (ULN) OR ≥60mL/min for subjects with creatinine levels > 1.5 x institutional ULN
Hepatic:
- Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) OR direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 ULN
- Aspartate aminotransferase (AST), alanine transaminase (ALT) or alkaline phosphatase (ALP) < 2.5 x ULN OR ≤ 5 x ULN for subjects with liver metastases
- Albumin ≥ 2.5 mg/dL
Coagulation (Blood Clotting) Tests:
- International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 x ULN unless subject is receiving anti-coagulant therapy as long as partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
- Activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN unless subject is receiving anti-coagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Investigational Treatment | Experimental | Drug: Pembrolizumab, Drug: Paclitaxel, Drug: CarboplatinSubjects with no prior therapy: * Pembrolizumab administered at 200 mg * Paclitaxel administered at 175mg/m2 * Carboplatin administered at an AUC of 6 Subjects with prior external beam radiation therapy (XRT) and/or platinum-based chemotherapy must initiate paclitaxel and carboplatin at a reduced dose: * Pembrolizumab administered at 200 mg * Paclitaxel administered at 135mg/m2 * Carboplatin administered at an AUC of 5 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Written informed consent and HIPAA authorization for release of personal health information prior to registration for protocol therapy.
- o NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
- Age ≥ 18 years at the time of consent.
- ECOG Performance Status of 0 or 1 within 28 days prior to registration for protocol therapy.
- Histological evidence of newly diagnosed Stage III or IV or recurrent endometrial carcinoma who have had definitive surgery for endometrial cancer (at least hysterectomy and bilateral salpingo-oophorectomy). Pathologic documentation of the recurrence (i.e., biopsy) will be performed per standard of care, at the treating physician's discretion. If a subject with recurrence is undergoing a biopsy for clinical indications and is willing and able, an optional collection of 3 frozen tissue cores of the recurrence site is requested for correlative analysis.
Key exclusion criteria (21 listed)
- Subjects with carcinosarcoma.
- Subjects who have a solitary central pelvic recurrence, which can be curatively resected.
- Hypersensitivity to pembrolizumab or any of its excipients.
- Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to registration for protocol therapy or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to registration for protocol therapy and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior registration for protocol therapy. This exception does not include carcinomatous meningitis, which is excluded regardless of clinical stability.
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 |
|---|---|---|
| PembrolizumabAlso: MK-3475, Keytruda®Pembrolizumab 200 mg will be administered every 3 weeks for all subjects | Drug | Investigational Treatment |
| PaclitaxelAlso: Taxol®For subjects with no prior therapy, paclitaxel will be dosed at 175mg/m2 and be administered as a 3-hour continuous IV infusion. Subjects with prior XRT/platinum-based chemotherapy must initiate paclitaxel at 135mg/m2 and be administered as a 3-hour continuous IV infusion. | Drug | Investigational Treatment |
| CarboplatinAlso: Paraplatin®For subjects with no prior therapy, carboplatin will be dosed at an AUC of 6 and given as an IV infusion in 250ml of D5W over 30 minutes. Subjects with prior XRT/platinum-based chemotherapy must initiate carboplatin at an AUC of 5 given as an IV infusion in 250ml of D5W over 30 minutes. | Drug | Investigational Treatment |
Primary outcome
Objective Response Rates (ORR)
Time frame: From start of treatment Day 1 (D1) and assessed for a maximum of 18 months
Objective response rate(ORR) is defined as the percentage of subjects with a partial response or complete response according to immune-related RECIST criteria. Immune-Related Response Criteria: Complete Response(irCR): Disappearance of all lesions in two consecutive observations not less than 4 wk apart. Partial Reponse (irPR): decrease in tumor burden ≥50 %relative to baseline confirmed by a consecutive assessment at least 4 wk after first documentation Stable Disease (irSD): not meeting criteria for irCR or irPR, in absence of irPD
1 secondary outcome
Proportion of Subjects Who Experience ≥ Grade 3 Toxicity According Per Common Toxicity Criteria for Adverse Effects (CTCAE) v4 Criteria
Time frame: From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Big Ten Cancer Research Consortium WebsiteLink provided by the sponsor.
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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.
Daniela Matei, M.D. study chair
Big Ten Cancer Research Consortium
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pembrolizumab, Paclitaxel and Carboplatin in people with Endometrial Cancer and Endometrial Adenocarcinoma, run by Daniela Matei, MD at 6 sites in United States.
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 24 inclusion and 21 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 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 30 Nov 2021). 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?
Objective Response Rates (ORR) (time frame: From start of treatment Day 1 (D1) and assessed for a maximum of 18 months). 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 2 Mar 2022.