Recurrent/Metastatic CarcinosarcomaPhase 2NCT05224999
Nivolumab for Recurrent/Metastatic Carcinosarcoma
A Phase 2 study testing nivolumab in people with Recurrent/Metastatic Carcinosarcoma, run by Yonsei University at 1 site in South Korea.
Trial summary
Carcinosarcoma is a malignant neoplasm that is composed of both epithelial and mesenchymal elements and aggressive tumor that are staged as high-grade cancer in NCCN guideline. They are regarded as rare aggressive malignancies with a high potential to develop distant metastases and are associated with an overall poor… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Recurrent/Metastatic Carcinosarcoma
- What is being tested?
- nivolumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Nov 2019to Dec 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed recurrent/metastatic carcinosarcoma
- ECOG performance status of 0 to 1
- ≥ 19 years of age
- At least 1 prior chemotherapy
- Patients who have at least 1 measurable disease per the RECIST Guideline Ver. 1.1 as confirmed by imaging within 28 days before randomization
- Subjects who meet the following criteria:
Show all 11Show fewer
- Absolute neutrophil count (ANC) ≥ 1500 /µ
- Platelet count ≥ 75,000/ µL
- Serum creatinine < 1.5 x upper limit of normal (ULN)
- AST (SGOT) and ALT (SGPT) < 3 x upper limit of normal (ULN) (If there is Liver Metastasis < 5 x upper limit of normal (ULN))
- Total bilirubin < 1.5 x upper limit of normal (ULN)
Who cannot join
- More than 4 prior cytotoxic agents
- Prior treatment with systemic PD-L1-directed therapy
- Patient who has had chemotherapy, radiotherapy, or biological therapy within 2 weeks prior to entering the study, or who has not recovered from the adverse events due to previous agents administered more than 2 weeks prior to study day
- Subjects with symptomatic central nervous system (CNS) metastases who are neurologically unstable or have required increasing doses of steroids within the 2 weeks prior to study entry to manage CNS symptoms
- Patients with multiple primary cancers (with the exception of completely resected basal cell carcinoma, stage I squamous cell carcinoma, carcinoma in situ, intramucosal carcinoma, or superficial bladder cancer, or any other cancer that has not recurred for at least 3 years)
- History of active non-infectious pneumonitis requiring treatment with steroids, or history or current signs of chronic interstitial lung disease
- Known active infection
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Severance Hospital, Yonsei University Health System
Seoul, 03722
Hyo Song Kim, 82-2-2228-8124, hyosong77@yuhs.ac
About this study
Official title: A Phase II Trial of Nivolumab for Recurrent/Metastatic Carcinosarcoma
Carcinosarcoma is a malignant neoplasm that is composed of both epithelial and mesenchymal elements and aggressive tumor that are staged as high-grade cancer in NCCN guideline. They are regarded as rare aggressive malignancies with a high potential to develop distant metastases and are associated with an overall poor survival. The aggressive nature of this malignancy coupled with a high relapse rate defines a poor clinical course for most patients. First line treatment of patients with advanced uterine carcinosarcoma with paclitaxel plus carboplatin achieved an objective response rate of 54% of patients. For this orphan tumor, carcinosarcoma, as these drugs would hypothetically act only on tissues with overexpression of PD-L1, they theoretically provide a more precise therapeutic effect on tumor cells with considerably less side effects. Therefore, the investigators suggest phase II trial of nivolumab for metastatic/recurred carcinosarcoma who have progressed after prior chemotherapy.
Read the detailed description
Single center, prospective phase II trial.
- Conditions
- Recurrent/Metastatic Carcinosarcoma
- Being tested
- nivolumab
- Keywords
- carcinosarcoma, nivolumab
- Medical subject headings
- Carcinosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nivolumabDrug
nivolumab 3mg/kg (every 2 weeks)
| Study group | Role | What they receive |
|---|---|---|
| nivolumab | Experimental | Not described Receives: Drug: nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free rate (PFR) at 6 months
proportion of patients who did not progress and were alive at 24 weeks (RECIST version 1.1)
Measured: at 6 months
Secondary outcomes (5)
Overall Response Rate (ORR) by RECIST version 1.1
Measured: 8 weeks
Progression-free survival (PFS) by RECIST version 1.1
Measured: 8 weeks
Overall survival (OS)
Measured: 8 weeks
Time to progression (TPP)
Measured: 8 weeks
Drug toxicity and safety analysis by CTCAE Version 5
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start13 Nov 2019
- Primary completionJan 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent/Metastatic CarcinosarcomaStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05224999
- Sponsor's protocol ID
- 4-2019-1104
- Status last verified
- Feb 2022
- First submitted
- 24 Jan 2022
- Last updated
- 4 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Nivolumab for Recurrent/Metastatic Carcinosarcoma
- ClinicalTrials.gov ID
- NCT05224999
- Acronym / sponsor ID
- 4-2019-1104
- Conditions
- Recurrent/Metastatic Carcinosarcoma
- Keywords
- carcinosarcoma, nivolumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 13 Nov 2019 (actual)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 4 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Carcinosarcoma is a malignant neoplasm that is composed of both epithelial and mesenchymal elements and aggressive tumor that are staged as high-grade cancer in NCCN guideline. They are regarded as rare aggressive malignancies with a high potential to develop distant metastases and are associated with an overall poor survival. The aggressive nature of this malignancy coupled with a high relapse rate defines a poor clinical course for most patients. First line treatment of patients with advanced uterine carcinosarcoma with paclitaxel plus carboplatin achieved an objective response rate of 54% of patients. For this orphan tumor, carcinosarcoma, as these drugs would hypothetically act only on tissues with overexpression of PD-L1, they theoretically provide a more precise therapeutic effect on tumor cells with considerably less side effects. Therefore, the investigators suggest phase II trial of nivolumab for metastatic/recurred carcinosarcoma who have progressed after prior chemotherapy.
Detailed description
Single center, prospective phase II trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| nivolumab | Experimental | Drug: nivolumab |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologically confirmed recurrent/metastatic carcinosarcoma
- ECOG performance status of 0 to 1
- ≥ 19 years of age
- At least 1 prior chemotherapy
- Patients who have at least 1 measurable disease per the RECIST Guideline Ver. 1.1 as confirmed by imaging within 28 days before randomization
Key exclusion criteria (7 listed)
- More than 4 prior cytotoxic agents
- Prior treatment with systemic PD-L1-directed therapy
- Patient who has had chemotherapy, radiotherapy, or biological therapy within 2 weeks prior to entering the study, or who has not recovered from the adverse events due to previous agents administered more than 2 weeks prior to study day
- Subjects with symptomatic central nervous system (CNS) metastases who are neurologically unstable or have required increasing doses of steroids within the 2 weeks prior to study entry to manage CNS symptoms
- Patients with multiple primary cancers (with the exception of completely resected basal cell carcinoma, stage I squamous cell carcinoma, carcinoma in situ, intramucosal carcinoma, or superficial bladder cancer, or any other cancer that has not recurred for at least 3 years)
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 |
|---|---|---|
| nivolumabnivolumab 3mg/kg (every 2 weeks) | Drug | nivolumab |
Primary outcome
Progression free rate (PFR) at 6 months
Time frame: at 6 months
proportion of patients who did not progress and were alive at 24 weeks (RECIST version 1.1)
5 secondary outcomes
Overall Response Rate (ORR) by RECIST version 1.1
Time frame: 8 weeks
Progression-free survival (PFS) by RECIST version 1.1
Time frame: 8 weeks
Overall survival (OS)
Time frame: 8 weeks
Time to progression (TPP)
Time frame: 8 weeks
Drug toxicity and safety analysis by CTCAE Version 5
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing nivolumab in people with Recurrent/Metastatic Carcinosarcoma, run by Yonsei University at 1 site in South Korea.
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 11 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 4 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hyo Song Kim (82-2-2228-8124, hyosong77@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free rate (PFR) at 6 months (time frame: at 6 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 4 Feb 2022.