Non Muscle Invasive Bladder CancerPhase 2CORE-001NCT04387461
Study of CG0070 Given in Combination With Pembrolizumab, in Non-Muscle Invasive Bladder Cancer, Unresponsive to Bacillus Calmette-Guerin
A Phase 2 study testing CG0070, Pembrolizumab Injection and n-dodecyl-B-D-maltoside in people with Non Muscle Invasive Bladder Cancer, run by CG Oncology, Inc. at 19 sites in 2 countries.
Trial summary
To evaluate the activity of intravesical administration of CG0070 and intravenous administration of Pembrolizumab in patients with tissue pathology-confirmed non-muscle invasive bladder cancer (NMIBC) who have Bacillus-Calmette-Guerin (BCG) unresponsive disease with carcinoma in situ (CIS) with or without Ta/T1… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Muscle Invasive Bladder Cancer
- What is being tested?
- CG0070, Pembrolizumab Injection and n-dodecyl-B-D-maltoside
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 19 sitesin 2 countries
- Study dates
- 8 Dec 2020to 28 May 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Pathologically confirmed NMIBC with CIS (with or without Ta/T1 disease)
- Unresponsive to prior BCG therapy (Lerner 2015) defined as persistent or recurrent CIS alone or with recurrent Ta/T1 (noninvasive papillary disease/tumor invades the sub- epithelial connective tissue) disease within 12 months of completion of adequate BCG therapy. An assessment within 15 months can also qualify when no assessment was performed within 12 months after completion of adequate BCG therapy.
- Adequate BCG is defined as at least 5 treatments with induction BCG followed by at least 2 BCG treatments as reinduction or maintenance
- Ineligible for radical cystectomy or refusal of radical cystectomy
- Adequate organ function
Who cannot join
- Immuno-deficient due to chronic steroid or other immunosuppressant use, HIV, or prior organ transplant
- Prior treatment with adenovirus-based cancer therapy
- Prior therapy with or intolerant to prior checkpoint inhibitor therapy
- Clinically significant or active cardiac disease
- Active autoimmune disease
Trial locations and contacts
19 sites in 2 countries.
19 sites in 2 countries
United States13 sites
Johns Hopkins Medical Institution
Baltimore, Maryland, 21287
Ohio State University
Columbus, Ohio, 43210
Chesapeake Urology
Hanover, Maryland, 21076
University of California - San Diego
La Jolla, California, 92093
Keystone Urology Specialists
Lancaster, Pennsylvania, 17604
New York University
New York, New York, 10003
University of California - Irvine
Orange, California, 92868
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Mayo Clinic - Rochester
Rochester, Minnesota, 55902-9823
Spokane Urology
Spokane, Washington, 99202
SUNY Upstate Medical University
Syracuse, New York, 13210
Moffitt Cancer Center
Tampa, Florida, 33612
Northwestern University
Tampa, Florida, 33612
South Korea6 sites
Chonnam National University Hwasun Hospital
Hwasun, 58128
Korea University Anam Hospital
Seoul, 02841
Seoul National University Hospital
Seoul, 03080
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul, 06591
Severance Hospital
Sinchon-dong
Pusan National University Yangsan Hospital
Yangsan, 50612
About this study
Official title: A Phase 2, Single Arm Study of CG0070 Combined With Pembrolizumab in Patients With Non Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus Calmette-Guerin (BCG)
To evaluate the activity of intravesical administration of CG0070 and intravenous administration of Pembrolizumab in patients with tissue pathology-confirmed non-muscle invasive bladder cancer (NMIBC) who have Bacillus-Calmette-Guerin (BCG) unresponsive disease with carcinoma in situ (CIS) with or without Ta/T1 papillary disease.
Read the detailed description
An opened label trial designed to evaluate CG0070 and DDM in combination with Pembrolizumab in patients with NMIBC who have failed prior BCG therapy.
The target population of 37 subjects with CIS with or without concomitant high-grade Ta or T1 papillary disease will be enrolled.
BCG failure is defined as persistent or recurrent disease within 12 months of completion of adequate BCG therapy.
- Conditions
- Non Muscle Invasive Bladder Cancer
- Being tested
- CG0070, Pembrolizumab Injection, n-dodecyl-B-D-maltoside
- Keywords
- high-grade Ta papillary disease, high-grade T1 papillary disease, carcinoma in situ, Bacillus-Calmette-Guerin Unresponsive
- Medical subject headings
- Non-Muscle Invasive Bladder Neoplasms, Carcinoma in Situ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CG0070Biological
Engineered Oncolytic Adenovirus
Pembrolizumab InjectionBiological
Also called KEYTRUDA®
Immune checkpoint inhibitor, Monoclonal antibody
n-dodecyl-B-D-maltosideOther
Also called DDM
Transduction-enhancing agent.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | CG0070 will be administered intravesically (IVE) following a sequence of bladder washes with 5% DDM and normal saline. CG0070 will be administered weekly x 6 on Day 1 to Week 6. If the patient shows persistent high-grade disease at Week 13, the patient will receive another cycle of 6 weekly treatments. If there is no disease present at Week 13 (e.g., complete response) then the patient will receive 3 weekly treatments.
Beginning at Week 25, patients will receive weekly x 3 treatments every 3 months through Week 49 then every 24 weeks thereafter.
Pembrolizumab will be given intravenous (IV) concurrently starting on Day 1 and continue every 6 weeks for up to 2 years. Receives: Biological: CG0070; Biological: Pembrolizumab Injection; Other: n-dodecyl-B-D-maltoside |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response rate in patients
Percentage of patients with a complete response as defined by FDA guidance document dated February 2018 for NMIBC.
Measured: 12 months
Secondary outcomes (4)
Incidence of adverse events when CG0070 administered intravesically when combined with pembrolizumab.
Percentage of patients with adverse events by grade as determined by NCI CTCAE v5.0
Measured: 12 months
Median duration of response (DoR)
Median duration of response in patients with a CR or PR
Measured: 12 months
Median overall survival (OS)
Median overall survival in months in patients
Measured: 12 months
Median progression free survival
Median duration of progression free survival of patients
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start8 Dec 2020
- Primary completion7 Mar 2023
- Study completion28 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non Muscle Invasive Bladder 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- CG Oncology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04387461
- Sponsor's protocol ID
- CG2003C
- Other IDs
- KEYNOTE-935, MK-3475-935
- Acronym
- CORE-001
- Status last verified
- Sep 2024
- First submitted
- 5 May 2020
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li R, Shah PH, Stewart TF, Nam JK, Bivalacqua TJ, Lamm DL, Uchio EM, Geynisman DM, Jacob JM, Meeks JJ, Dickstein R, Pearce SM, Kang SH, Jung SI, Kamat AM, Burke JM, Keegan KA, Steinberg GD. Oncolytic adenoviral therapy plus pembrolizumab in BCG-unresponsive non-muscle-invasive bladder cancer: the phase 2 CORE-001 trial. Nat Med. 2024 Aug;30(8):2216-2223. doi: 10.1038/s41591-024-03025-3. Epub 2024 Jun 6.
PubMed 38844794
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Single Arm Study of CG0070 Combined With Pembrolizumab in Patients With Non Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus Calmette-Guerin (BCG)
- ClinicalTrials.gov ID
- NCT04387461
- Acronym / sponsor ID
- CORE-001 / CG2003C
- Conditions
- Non Muscle Invasive Bladder Cancer
- Keywords
- high-grade Ta papillary disease, high-grade T1 papillary disease, carcinoma in situ, Bacillus-Calmette-Guerin Unresponsive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- CG Oncology, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 8 Dec 2020 (actual)
- Primary completion
- 7 Mar 2023 (actual)
- Study completion
- 28 May 2024 (actual)
- First posted
- 13 May 2020 (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 evaluate the activity of intravesical administration of CG0070 and intravenous administration of Pembrolizumab in patients with tissue pathology-confirmed non-muscle invasive bladder cancer (NMIBC) who have Bacillus-Calmette-Guerin (BCG) unresponsive disease with carcinoma in situ (CIS) with or without Ta/T1 papillary disease.
Detailed description
An opened label trial designed to evaluate CG0070 and DDM in combination with Pembrolizumab in patients with NMIBC who have failed prior BCG therapy.
The target population of 37 subjects with CIS with or without concomitant high-grade Ta or T1 papillary disease will be enrolled.
BCG failure is defined as persistent or recurrent disease within 12 months of completion of adequate BCG therapy.
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 | Biological: CG0070, Biological: Pembrolizumab Injection, Other: n-dodecyl-B-D-maltosideCG0070 will be administered intravesically (IVE) following a sequence of bladder washes with 5% DDM and normal saline. CG0070 will be administered weekly x 6 on Day 1 to Week 6. If the patient shows persistent high-grade disease at Week 13, the patient will receive another cycle of 6 weekly treatments. If there is no disease present at Week 13 (e.g., complete response) then the patient will receive 3 weekly treatments. Beginning at Week 25, patients will receive weekly x 3 treatments every 3 months through Week 49 then every 24 weeks thereafter. Pembrolizumab will be given intravenous (IV) concurrently starting on Day 1 and continue every 6 weeks for up to 2 years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Pathologically confirmed NMIBC with CIS (with or without Ta/T1 disease)
- Unresponsive to prior BCG therapy (Lerner 2015) defined as persistent or recurrent CIS alone or with recurrent Ta/T1 (noninvasive papillary disease/tumor invades the sub- epithelial connective tissue) disease within 12 months of completion of adequate BCG therapy. An assessment within 15 months can also qualify when no assessment was performed within 12 months after completion of adequate BCG therapy.
- Ineligible for radical cystectomy or refusal of radical cystectomy
- Adequate organ function
Key exclusion criteria (5 listed)
- Immuno-deficient due to chronic steroid or other immunosuppressant use, HIV, or prior organ transplant
- Prior treatment with adenovirus-based cancer therapy
- Prior therapy with or intolerant to prior checkpoint inhibitor therapy
- Clinically significant or active cardiac disease
- Active autoimmune disease
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 |
|---|---|---|
| CG0070Engineered Oncolytic Adenovirus | Biological | Single Arm |
| Pembrolizumab InjectionAlso: KEYTRUDA®Immune checkpoint inhibitor, Monoclonal antibody | Biological | Single Arm |
| n-dodecyl-B-D-maltosideAlso: DDMTransduction-enhancing agent. | Other | Single Arm |
Primary outcome
Complete response rate in patients
Time frame: 12 months
Percentage of patients with a complete response as defined by FDA guidance document dated February 2018 for NMIBC.
4 secondary outcomes
Incidence of adverse events when CG0070 administered intravesically when combined with pembrolizumab.
Time frame: 12 months
Median duration of response (DoR)
Time frame: 12 months
Median overall survival (OS)
Time frame: 12 months
Median progression free survival
Time frame: 12 months
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 25 Sep 2024.
- Derived from this study: PubMed 38844794Li R, Shah PH, Stewart TF, Nam JK, Bivalacqua TJ, Lamm DL, Uchio EM, Geynisman DM, Jacob JM, Meeks JJ, Dickstein R, Pearce SM, Kang SH, Jung SI, Kamat AM, Burke JM, Keegan KA, Steinberg GD. Oncolytic adenoviral therapy plus pembrolizumab in BCG-unresponsive non-muscle-invasive bladder cancer: the phase 2 CORE-001 trial. Nat Med. 2024 Aug;30(8):2216-2223. doi: 10.1038/s41591-024-03025-3. Epub 2024 Jun 6.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
19 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CG0070, Pembrolizumab Injection and n-dodecyl-B-D-maltoside in people with Non Muscle Invasive Bladder Cancer, run by CG Oncology, Inc. at 19 sites in 2 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 6 inclusion and 5 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 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, 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?
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?
Complete response rate in patients (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04387461, which also lists 1 linked publication.
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 25 Sep 2024.