Clear Cell Renal Cell CarcinomaPhase 1NCT02575222
Study of Neoadjuvant Nivolumab in Patients With Non-metastatic Stage II-IV Clear Cell Renal Cell Carcinoma
A Phase 1 study testing Nivolumab in people with Clear Cell Renal Cell Carcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
This study will evaluate the use of nivolumab before surgery in patients with high-risk clear cell renal cell carcinoma who are eligible for nephrectomy. Nivolumab is an antibody that may help activate the immune system by blocking the function of an inhibitory molecule, Programmed cell death-1 (PD-1). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clear Cell Renal Cell Carcinoma
- What is being tested?
- Nivolumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to 9 Jun 2020
- 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
- Confirmed non-metastatic high-risk clear cell renal cell carcinoma (T2a-T4NanyM0 or TanyN1M0)
- Schedule to undergo either partial or radical nephrectomy as part of treatment plan
- Patient agrees to have a tumor biopsy
- ECOG performance status of 0 or 1
- Adequate organ and marrow function defined by study-specified laboratory tests
- Must use acceptable form of birth control while on study and for approximately 31 weeks post-treatment completion
- Willingness and ability to comply with scheduled visits, treatment plans, lab tests and other study procedures
Who cannot join
- Other active malignancies within last 3 years (with some exceptions for skin, prostate, cervical, or breast cancer)
- Need for urgent or emergent nephrectomy to relieve symptoms
- Prior treatment for RCC including surgery, radiation, thermoablation or systemic therapy
- Surgery within 28 days of starting study treatment (some exceptions for minor procedures)
- Received live vaccine for infectious diseases within 28 days of starting study treatment
- Prior treatment with any antibody or drug targeting T-cell costimulation or immune checkpoint pathways (anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, etc)
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- Use of immunosuppressive doses of systemic medications within 14 days prior to starting study drug.
- Current use of immunosuppressive agents
- History of severe hypersensitivity reaction to other monoclonal antibodies
- Current signs or symptoms of severe progressive or uncontrolled hepatic, hematologic, gastrointestinal, endocrine, pulmonary or cardiac disease other than directly related to RCC
- Uncontrolled psychiatric illness/social situations that would limit compliance with study requirements.
- Active infection requiring therapy.
- Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
- Positive tests for Hepatitis B surface antigen or Hepatitis C ribonucleic acid (RNA).
- History of autoimmune disease or syndrome requiring systemic steroids or immunosuppressants (some exceptions apply).
- Pulse oximetry of <92% on room air
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country.
United States1 site
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21287
About this study
Official title: Phase I Study of Neoadjuvant Nivolumab in Patients With Non-metastatic High-risk Clear Cell Renal Cell Carcinoma
This study will evaluate the use of nivolumab before surgery in patients with high-risk clear cell renal cell carcinoma who are eligible for nephrectomy. Nivolumab is an antibody that may help activate the immune system by blocking the function of an inhibitory molecule, Programmed cell death-1 (PD-1).
- Conditions
- Clear Cell Renal Cell Carcinoma
- Being tested
- Nivolumab
- Keywords
- Immunotherapy, PD-1, anti-PD-1, antibody, Kidney Cancer, RCC, non-metastatic
- Medical subject headings
- Carcinoma, Renal Cell, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
Also called MDX-1106, BMS-936558, Opdivo
3 mg/kg, IV (in the vein) on day 1 of each 2-week cycle, for a total of 3 doses prior to nephrectomy.
| Study group | Role | What they receive |
|---|---|---|
| Nivolumab | Experimental | 3 mg/kg, IV (in the vein) on day 1 of each 2-week cycle, for a total of 3 doses prior to nephrectomy. Receives: Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as assessed by number of participants experiencing adverse events
Number of participants experiencing any adverse event as defined by Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Measured: From the first dose of nivolumab treatment through 100 days post-surgery
Secondary outcomes (5)
Objective Tumor Response Rate (by RECIST)
Number of patients achieving a complete response (CR) or partial response (PR) by Response Evaluation Criteria in Solid Tumors (RECIST)
Measured: Assessed at baseline, prior to surgery, and 3 months after surgery
Objective Tumor Response Rate (by irRC)
Number of patients achieving a complete response (CR) or partial response (PR) by immune-related response criteria (irRC)
Measured: Assessed at baseline, prior to surgery, and 3 months after surgery
Quality of Life as assessed by the Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI) -15 questionnaire
Total score range 0-60 with higher scores indicating a less symptomatic respondent.
Measured: Baseline, 2 weeks, 4 weeks, prior to surgery, and at 1-, 3-, 6-, and 12-months after surgery
Metastasis-Free Survival
Number of months without evidence of metastasis.
Measured: 12 months post-operatively, then every 6 months for 5 years
Overall Survival
Number of months alive.
Measured: 12 months post-operatively, then every 6 months for 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2015 (estimated)
- Study startFeb 2016
- Primary completion9 Jun 2020
- Study completion9 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clear Cell Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Mohamad E Allaf, M.D, Principal investigator, Department of Urology and The Brady Urological Institute at Johns Hopkins
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02575222
- Sponsor's protocol ID
- J15179
- Other IDs
- IRB00068726
- Status last verified
- Jun 2020
- First submitted
- 6 Oct 2015
- Last updated
- 12 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Neoadjuvant Nivolumab in Patients With Non-metastatic High-risk Clear Cell Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT02575222
- Acronym / sponsor ID
- J15179
- Conditions
- Clear Cell Renal Cell Carcinoma
- Keywords
- Immunotherapy, PD-1, anti-PD-1, antibody, Kidney Cancer, RCC, non-metastatic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- Feb 2016 (actual)
- Primary completion
- 9 Jun 2020 (actual)
- Study completion
- 9 Jun 2020 (actual)
- First posted
- 14 Oct 2015 (estimated)
- 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.
This study will evaluate the use of nivolumab before surgery in patients with high-risk clear cell renal cell carcinoma who are eligible for nephrectomy. Nivolumab is an antibody that may help activate the immune system by blocking the function of an inhibitory molecule, Programmed cell death-1 (PD-1).
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: Nivolumab3 mg/kg, IV (in the vein) on day 1 of each 2-week cycle, for a total of 3 doses prior to nephrectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Confirmed non-metastatic high-risk clear cell renal cell carcinoma (T2a-T4NanyM0 or TanyN1M0)
- Schedule to undergo either partial or radical nephrectomy as part of treatment plan
- Patient agrees to have a tumor biopsy
- ECOG performance status of 0 or 1
- Adequate organ and marrow function defined by study-specified laboratory tests
Key exclusion criteria (17 listed)
- Other active malignancies within last 3 years (with some exceptions for skin, prostate, cervical, or breast cancer)
- Need for urgent or emergent nephrectomy to relieve symptoms
- Prior treatment for RCC including surgery, radiation, thermoablation or systemic therapy
- Surgery within 28 days of starting study treatment (some exceptions for minor procedures)
- Received live vaccine for infectious diseases within 28 days of starting study treatment
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 |
|---|---|---|
| NivolumabAlso: MDX-1106, BMS-936558, Opdivo3 mg/kg, IV (in the vein) on day 1 of each 2-week cycle, for a total of 3 doses prior to nephrectomy. | Drug | Nivolumab |
Primary outcome
Safety as assessed by number of participants experiencing adverse events
Time frame: From the first dose of nivolumab treatment through 100 days post-surgery
Number of participants experiencing any adverse event as defined by Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0)
5 secondary outcomes
Objective Tumor Response Rate (by RECIST)
Time frame: Assessed at baseline, prior to surgery, and 3 months after surgery
Objective Tumor Response Rate (by irRC)
Time frame: Assessed at baseline, prior to surgery, and 3 months after surgery
Quality of Life as assessed by the Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI) -15 questionnaire
Time frame: Baseline, 2 weeks, 4 weeks, prior to surgery, and at 1-, 3-, 6-, and 12-months after surgery
Metastasis-Free Survival
Time frame: 12 months post-operatively, then every 6 months for 5 years
Overall Survival
Time frame: 12 months post-operatively, then every 6 months for 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2020.
- Individual participant dataSharing planned: No
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Renal Cell Carcinoma
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.
Mohamad E Allaf, M.D principal investigator
Department of Urology and The Brady Urological Institute at Johns Hopkins
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 Nivolumab in people with Clear Cell Renal Cell Carcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins 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 7 inclusion and 17 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 12 Jun 2020. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety as assessed by number of participants experiencing adverse events (time frame: From the first dose of nivolumab treatment through 100 days post-surgery). 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 12 Jun 2020.