Metastatic sRCCPhase 1NCT03483883
Avelumab/Gemcitabine in Sarcomatoid RCC
A Phase 1 study testing Avelumab and Gemcitabine in people with Metastatic sRCC, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
To determine the feasibility and safety of avelumab and gemcitabine combination therapy in patients with metastatic sRCC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic sRCC
- What is being tested?
- Avelumab and Gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2018to 10 Feb 2021
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologic evidence of metastatic RCC with sarcomatoid features (≥10% sarcomatoid component) or poor-risk RCC prognostic features (as defined by IMDC criteria). (14) An outside pathology report is sufficient for study eligibility. However, pathology should still be obtained as possible for internal institutional pathology review.
- ≥ 18 years of age.
- Phase I dose-escalation portion only:
- Patients must have ≤3 prior systemic treatment regimens with recent evidence of disease progression by RECIST 1.1 criteria. Previous treatment with immune-checkpoint inhibitor therapy is allowable as a line of systemic therapy for the phase I portion. Prior systemic therapy in the adjuvant treatment setting is allowable as a prior line of therapy.
- Phase Ib dose-expansion portion only:
- Patients must have been treated with 0 or 1 prior lines of systemic therapy. Previous treatment with immune-checkpoint inhibitor therapy is allowable as a line of systemic therapy for the phase Ib expansion portion.
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- No prior therapy with gemcitabine chemotherapy.
- ECOG performance status of 0-1. Patients must have primary or metastatic FFPE tissue available for histologic confirmation and possible determination of percent sarcomatoid component (if applicable).
- Outside pathology report is sufficient for study eligibility. However, pathology should still be obtained as possible for internal institutional pathology review.
- Patients with history of treated brain metastases are eligible if off systemic corticosteroids for at least 2 weeks.
- Patients must have normal organ function, as confirmed by laboratory values obtained ≤ 14 days prior to the first day of study therapy:
- Hematologic: Absolute neutrophil count (ANC) ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L, and hemoglobin ≥ 9 g/dL (may have been transfused) Hepatic: Total bilirubin level ≤ 1.5 × the upper limit of normal (ULN) range and AST and ALT levels ≤ 2.5 × ULN or AST and ALT levels ≤ 5 x ULN (for subjects with documented metastatic disease to the liver).
- Renal: Estimated creatinine clearance ≥ 45 mL/min using Cockroft Gault formula.
- Patients must have a projected life expectancy of at least 3 months.
- PREGNANCY AND CONTRACEPTION:
- Pregnancy test: Negative serum or urine pregnancy test at screening for women of childbearing potential.
- Contraception: Highly effective contraception for both male and female subjects throughout the study and for at least 30 days after last avelumab treatment administration if the risk of conception exists.
- In addition, women must not breastfeed while on this study as study drugs may also affect a breast-feeding child. Pregnant women and women who are breastfeeding are not allowed to participate in this study.
Who cannot join
- IMMUNOSUPRESSANTS: Current use of immunosuppressive medication, EXCEPT for the following: a. intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection); b. Systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or equivalent; c. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).
- AUTOIMMUNE DISEASE: Active autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent. Patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment are eligible.
- ORGAN TRANSPLANTATION: Prior organ transplantation including allogenic stem-cell transplantation.
- INFECTIONS: Active infection requiring systemic therapy.
- HIV/AIDS: Known history of testing positive for HIV or known acquired immunodeficiency syndrome, or positive HIV test result at screening.
- HEPATITIS: Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or HCV RNA if anti-HCV antibody screening test positive)
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- VACCINATION: Vaccination within 4 weeks of the first dose of avelumab and while on trials is prohibited except for administration of inactivated vaccines.
- HYPERSENSITIIVTY TO STUDY DRUG: Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI CTCAE v4.03 Grade ≥ 3).
- CARDIOVASCULAR DISEASE: Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication.
- OTHER PERSISTING TOXICITIES: Persisting toxicity related to prior therapy (NCI CTCAE v. 4.03 Grade > 1); however, alopecia, sensory neuropathy Grade ≤ 2, or other Grade ≤ 2 not constituting a safety risk based on investigator's judgment are acceptable.
- Other severe acute or chronic medical conditions including immune colitis, inflammatory bowel disease, immune pneumonitis, pulmonary fibrosis or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Phase I/IB Study of Avelumab in Combination With Gemcitabine for Advanced Renal Cell Carcinoma With Sarcomatoid Differentiation
To determine the feasibility and safety of avelumab and gemcitabine combination therapy in patients with metastatic sRCC.
- Conditions
- Metastatic sRCC
- Being tested
- Avelumab, Gemcitabine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvelumabDrug
Avelumab IV 10 mg/kg every 2 weeks
GemcitabineDrug
Dose Level 1: Gemcitabine 1250 mg/m2 IV every 2 weeks Dose Level 2: 1500 mg/m2 IV every 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Not described Receives: Drug: Avelumab; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2018
- Study start19 Mar 2018
- Primary completion22 Jul 2020
- Study completion10 Feb 2021
Why it stopped: The study was terminated due to protracted accrual and limited patient engagement in the setting of rapidly changing treatment paradigms for advanced RCC with sarcomatoid features and/or intermediate/poor risk clinical features.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic sRCCStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vivek Narayan, MD, Principal investigator, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03483883
- Sponsor's protocol ID
- UPCC 02818
- Status last verified
- Aug 2022
- First submitted
- 23 Mar 2018
- Last updated
- 26 Aug 2022
- Results posted
- No
- 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 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/IB Study of Avelumab in Combination With Gemcitabine for Advanced Renal Cell Carcinoma With Sarcomatoid Differentiation
- ClinicalTrials.gov ID
- NCT03483883
- Acronym / sponsor ID
- UPCC 02818
- Conditions
- Metastatic sRCC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated due to protracted accrual and limited patient engagement in the setting of rapidly changing treatment paradigms for advanced RCC with sarcomatoid features and/or intermediate/poor risk clinical features.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- 19 Mar 2018 (actual)
- Primary completion
- 22 Jul 2020 (actual)
- Study completion
- 10 Feb 2021 (actual)
- First posted
- 30 Mar 2018 (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.
To determine the feasibility and safety of avelumab and gemcitabine combination therapy in patients with metastatic sRCC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: Avelumab, Drug: Gemcitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Histologic evidence of metastatic RCC with sarcomatoid features (≥10% sarcomatoid component) or poor-risk RCC prognostic features (as defined by IMDC criteria). (14) An outside pathology report is sufficient for study eligibility. However, pathology should still be obtained as possible for internal institutional pathology review.
- ≥ 18 years of age.
- Phase I dose-escalation portion only:
- Patients must have ≤3 prior systemic treatment regimens with recent evidence of disease progression by RECIST 1.1 criteria. Previous treatment with immune-checkpoint inhibitor therapy is allowable as a line of systemic therapy for the phase I portion. Prior systemic therapy in the adjuvant treatment setting is allowable as a prior line of therapy.
- Patients must have been treated with 0 or 1 prior lines of systemic therapy. Previous treatment with immune-checkpoint inhibitor therapy is allowable as a line of systemic therapy for the phase Ib expansion portion.
Key exclusion criteria (11 listed)
- IMMUNOSUPRESSANTS: Current use of immunosuppressive medication, EXCEPT for the following: a. intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection); b. Systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or equivalent; c. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).
- AUTOIMMUNE DISEASE: Active autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent. Patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment are eligible.
- ORGAN TRANSPLANTATION: Prior organ transplantation including allogenic stem-cell transplantation.
- INFECTIONS: Active infection requiring systemic therapy.
- HIV/AIDS: Known history of testing positive for HIV or known acquired immunodeficiency syndrome, or positive HIV test result at screening.
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 |
|---|---|---|
| AvelumabAvelumab IV 10 mg/kg every 2 weeks | Drug | Single Arm |
| GemcitabineDose Level 1: Gemcitabine 1250 mg/m2 IV every 2 weeks Dose Level 2: 1500 mg/m2 IV every 2 weeks | Drug | Single Arm |
Primary outcome
Number of Adverse Events
Time frame: 36 months
Results and safety
The study was stopped early (reason given: The study was terminated due to protracted accrual and limited patient engagement in the setting of rapidly changing treatment paradigms for advanced RCC with sarcomatoid features and/or intermediate/poor risk clinical features.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2022.
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.
Vivek Narayan, MD principal investigator
Abramson Cancer Center at Penn Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Avelumab and Gemcitabine in people with Metastatic sRCC, run by Abramson Cancer Center at Penn Medicine at 1 site 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 18 inclusion and 11 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: stopped early, as of the sponsor's last update on 26 Aug 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 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 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?
The study was stopped early (reason given: The study was terminated due to protracted accrual and limited patient engagement in the setting of rapidly changing treatment paradigms for advanced RCC with sarcomatoid features and/or intermediate/poor risk clinical features.). Results are not available in the source record.
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 Adverse Events (time frame: 36 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 26 Aug 2022.