Pancreatic Cancer Stage IVPhase 2NCT04953962
Study of CBP501/Cisplatin/Nivolumab Combinations in Advanced Pancreatic Cancer
A Phase 2 study testing CBP501 (16), CBP501 (25) and Cisplatin in people with Pancreatic Cancer Stage IV, run by CanBas Co. Ltd. at 20 sites in United States.
Trial summary
Multicenter, randomized, open-label, parallel group phase 2 study to assess the efficacy and tolerance of four combinations of CBP501, cisplatin, and nivolumab administered once every 21 days to patients with stage IV exocrine pancreatic cancer and WBC < 10,000/mm3 at screening. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer Stage IV
- What is being tested?
- CBP501 (16), CBP501 (25) and Cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 20 sitesUnited States
- Study dates
- 18 Dec 2021to 14 Apr 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent obtained prior to initiation of any study-specific procedures and treatment;
- Patients with pathologically confirmed stage IV exocrine pancreatic cancer who have received at least two lines of systemic therapy for metastatic disease. Up to 10 of prior lines of systemic therapy (including prior cisplatin), chemoradiotherapy, radiotherapy or investigational agents the patient has received are allowed in order to be eligible, as long as all eligibility criteria are met, with the exception that a patient must not have received more than two prior lines incorporating anti-PD-1, anti-PD-L1, or anti-CTLA-4 immune checkpoint blockade.
- Patients who have received prior anti-PD-1, anti-PD-L1, or anti-CTLA-4 immune checkpoint blockade therapy must have tolerated therapy with no evidence of grade 4 toxicity or an immune-related event (any grade) that required treatment discontinuation. Patients who experienced an endocrine related dysfunction are eligible, provided they are on stable hormone replacement therapy;
- Male or female patients aged ≥ 18 years at time of informed consent;
- ECOG Performance Status (PS) 0-1;
- Life expectancy > 3 months;
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- Previous anticancer treatment must be discontinued at least 3 weeks prior to the initiation of study treatment (with the exception of 6 weeks for mitomycin C; 6 weeks for anti-androgen therapy if discontinued prior to treatment initiation, and 8 weeks for bicalutamide);
- Adequate bone marrow reserve, cardiac, liver, renal and metabolic function:
- white blood cell count (WBC) <10,000/mm3;
- absolute neutrophil count (ANC) ≥ 1,500/mm3;
- platelet count ≥ 100,000/mm3;
- hemoglobin ≥ 9 g/dL;
- creatinine phosphokinase isozymes CPK-MB and CPK-MM ≤ upper limit of normal (ULN);
- serum troponin T levels within normal limits;
- bilirubin ≤ 1.5 x ULN;
- alanine aminotransferase (ALT, SGPT) and aspartate aminotransferase (AST, SGOT) ≤ 2.5 x ULN (≤ 5 x ULN if liver metastases are present);
- INR ≤ 1.5 x ULN;
- serum creatinine ≤ ULN or creatinine clearance ≥ 60 mL/min (by Cockcroft \& Gault formula or alternate calculation by 24hr urine collection). Patients with serum creatinine ≤ ULN and clearance between 45 to 59 mL/min should reduce cisplatin dose by 50%;
- serum potassium ≥ 3.0 and ≤ 5.5 mmol/L;
- serum calcium ≥ 8.0 and ≤ 11.5 mg/dL (≥ 2.0 and ≤ 2.9 mmol/L);
- serum magnesium ≥ 1.2 and ≤ 3.0 mg/dL (≥ 0.5 and ≤ 1.23 mmol/L);
- Female patients of child-bearing potential must have a negative serum pregnancy test and use at least one form of contraception as approved by the investigator for 4 weeks prior to initiating study treatment and for 14 months after the last dose of study drug . For the purposes of this study, child-bearing potential is defined as "all female patients unless they are post-menopausal for at least 3 years or surgically sterile;
- Male patients must use a form of barrier contraception approved by the investigator during the study and for 14 months after the last dose of study drug.
- Ability to cooperate with study treatment and follow-up.
Who cannot join
- Radiation therapy to >30% of bone marrow prior to study entry;
- Prior chemotherapy with nitrosoureas, prior mitomycin C cumulative dose ≥ 25 mg/m2, prior bone marrow transplant, or prior intensive chemotherapy with stem cell support;
- Presence of any serious concomitant systemic disorders incompatible with the study in the opinion of the investigator (e.g., uncontrolled congestive heart failure, active infection, etc.);
- Any previous history of another malignancy (other than cured basal cell or squamous cell carcinoma of the skin or cured in-situ carcinoma) within 5 years of study entry;
- Presence of any significant central nervous system (CNS) or psychiatric disorder(s) that would hamper the patient's compliance;
- Evidence of peripheral neuropathy grade ≥ 2;
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- Treatment with any other investigational agent or participation in another clinical trial within 28 days prior to study entry;
- Pregnant or breast-feeding patients or any patient with child-bearing potential not using adequate contraception;
- Known HIV, HBV, or HCV infection (excluding cured HBV and/or cured HCV infection);
- Active CNS metastases; however, patients with CNS metastases will be eligible if they have been treated and are stable without symptoms for 4 weeks after completion of treatment, with image documentation required, and must be off steroids;
- Who require chronic systemic steroid therapy or on any other form of immunosuppressive medication;
- Has received a live-virus vaccination within 30 days of planned treatment start;
- With known risk factors for bowel perforation, i.e., history of diverticulitis, intra-abdominal abscess, intestinal obstruction, or abdominal carcinomatosis;
- Has an active autoimmune disease or a documented history of autoimmune disease;
- Has a history pneumonitis or interstitial lung disease.
- Patients who were permanently discontinued from prior immunotherapy due to immune-related adverse events.
- Patients who are platinum and PD-1/PD-L1 inhibitor double refractory.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
University of Michigan hospital
Ann Arbor, Michigan, 48109
Illinois Cancer Specialists
Arlington Heights, Illinois, 60005
Virginia Cancer Specialists, PC
Arrington, Virginia, 22205
University of Colorado Cancer Center
Aurora, Colorado, 80045
Texas Oncology-Austin Midtown
Austin, Texas, 78705
Oncology Hematology Care, Inc.
Cincinnati, Ohio, 45245
Mary Crowley Medical Research Center
Dallas, Texas, 75230
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246
James D Sanchez
Henderson, Nevada, 89052
Ochsner Clinic Foundation
Los Angeles, California, 70121
Texas Oncology-McAllen South Second Street
McAllen, Texas, 78503
Texas Oncology- McKinney
McKinney, Texas, 75071
Minnesota oncology Hematology, P.A.
Minneapolis, Minnesota, 55404
Medical Oncology Hematology Consultants, PA
Newark, Delaware, 19713
Texas Oncology-San Antonio Northeast
San Antonio, Texas, 78217
Northwest Medical Specialties
Tacoma, Washington, 98405
Baylor Scott & White Medical Center
Temple, Texas, 76508
Arizona Oncology Associates, PC-HOPE
Tucson, Arizona, 85704
Texas Oncology-Northeast Texas
Tyler, Texas, 75702
Northwest Cancer Specialists, P.C.
Vancouver, Washington, 98684
About this study
Official title: Multicenter, Randomized, Parallel Group, Phase 2 to Establish the Efficacy and Safety of Combinations of CBP501, Cisplatin, and Nivolumab for ≥3rd Line Treatment of Patients With Exocrine Pancreatic Cancer and WBC <10,000/mm3 at Screening
Multicenter, randomized, open-label, parallel group phase 2 study to assess the efficacy and tolerance of four combinations of CBP501, cisplatin, and nivolumab administered once every 21 days to patients with stage IV exocrine pancreatic cancer and WBC < 10,000/mm3 at screening.
Read the detailed description
Multicenter, randomized, open-label, parallel group phase 2 study to assess the efficacy and tolerance of four combinations of CBP501, cisplatin, and nivolumab administered once every 21 days to patients with stage IV exocrine pancreatic cancer and WBC < 10,000/mm3 at screening. Patients will be randomized 1:1:1:1 to the following four treatment groups, with randomization stratified by ECOG PS (0 vs 1) and liver metastasis (present vs absent):
- CBP501 25 mg/m2 + cisplatin 60 mg/m2 + nivolumab 240 mg
- CBP501 16 mg/m2 + cisplatin 60 mg/m2 + nivolumab 240 mg
- CBP501 25 mg/m2 + cisplatin 60 mg/m2
- Cisplatin 60 mg/m2 + nivolumab 240 mg No more than 4 cycles of combination therapy may be administered but patients who remain progression-free after 4 cycles may receive up to 6 additional cycle of single-agent nivolumab.
A Fleming two-stage design will be used. For each study arm, the null hypothesis that the true percentage of patients progression-free at 3 months is 10% will be tested against a one-sided alternative. In the first stage, 9 patients will be accrued to each study arm. In the first stage, if there are 1 or fewer patient progression-free at 3 months the study will be stopped for futility and if there are 4 or more patients progression-free at 3 months the study will stopped and the null hypothesis rejected. Otherwise, 14 additional patients will be accrued to the study arm for a total of 23. The null hypothesis will be rejected if 6 or more of 23 patients are progression-free at 3 months. This design yields a type I error rate of 2.5% and power of 80% when the true percentage of patients progression-free at 3 months is 35%.
- Conditions
- Pancreatic Cancer Stage IV
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBP501 (16)Drug
Also called CBP501
16 mg/m2
CBP501 (25)Drug
Also called CBP501
25 mg/m2
CisplatinDrug
Also called CDDP
60mg/m2
NivolumabDrug
Also called Opdivo
240 mg
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: CBP501 (25) + Cisplatin + Nivolumab | Experimental | CBP501 25mg/m2 and Cisplatin 60mg/m2 will be administered simultaneously. Nivolumab 240mg will be administered following the completion of CBP501 and cisplatin infusions. Receives: Drug: CBP501 (25); Drug: Cisplatin; Drug: Nivolumab |
| Arm 2: CBP501 (16) + Cisplatin + Nivolumab | Experimental | CBP501 16mg/m2 and Cisplatin 60mg/m2 will be administered simultaneously. Nivolumab 240mg will be administered following the completion of CBP501 and cisplatin infusions. Receives: Drug: CBP501 (16); Drug: Cisplatin; Drug: Nivolumab |
| Arm 3: CBP501 (25) + Cisplatin | Experimental | CBP501 25mg/m2 and Cisplatin 60mg/m2 will be administered simultaneously. Receives: Drug: CBP501 (25); Drug: Cisplatin |
| Arm 4: Cisplatin + Nivolumab | Experimental | Cisplatin 60mg/m2 will be administered as infusion and then Nivolumab 240mg will be administered. Receives: Drug: Cisplatin; Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Three-month progression free survival rate (3M PFSR)
Tumor assessment by RECIST v.1.1 criteria will be performed at screening, every 8 weeks starting after Cycle 1 Day 1, at the End-of-Treatment visit, and every 3 months after the End-of-Treatment visit until disease progression is observed.
Measured: 3 months after treatment
Secondary outcomes (6)
Safety profiles of the combinations of CBP501, cisplatin, and nivolumab administered once every 21 days
Safety will be assessed throughout the study through clinical and laboratory safety evaluations. These include physical examinations, vital sign measurements, 12-lead ECGs, laboratory safety tests (hematology, INR, serum chemistry, serum cardiac markers), and clinical adverse experience monitoring. Adverse events will be evaluated at each visit throughout the study and assigned a grade, defined by NCI-CTCAE version 5.0 criteria, and relationship to study treatment (unrelated, related).
Measured: One year
Progression-free survival (PFS)
Tumor assessment by RECIST v.1.1 criteria will be performed at screening, every 8 weeks starting after Cycle 1 Day 1, at the End-of-Treatment visit, and every 3 months after the End-of-Treatment visit until disease progression is observed.
Measured: one year
Confirmed and timepoint objective response rates (cORR/ORR)
Tumor assessment by RECIST v.1.1 criteria will be performed at screening, every 8 weeks starting after Cycle 1 Day 1, at the End-of-Treatment visit, and every 3 months after the End-of-Treatment visit until disease progression is observed.
Measured: one year
Duration of responses (DoR)
Tumor assessment by RECIST v.1.1 criteria will be performed at screening, every 8 weeks starting after Cycle 1 Day 1, at the End-of-Treatment visit, and every 3 months after the End-of-Treatment visit until disease progression is observed.
Measured: one year
disease control rate (DCR: CR + PR + SD ≥12 weeks)
Tumor assessment by RECIST v.1.1 criteria will be performed at screening, every 8 weeks starting after Cycle 1 Day 1, at the End-of-Treatment visit, and every 3 months after the End-of-Treatment visit until disease progression is observed.
Measured: one year
Overall survival (OS)
Tumor assessment by RECIST v.1.1 criteria will be performed at screening, every 8 weeks starting after Cycle 1 Day 1, at the End-of-Treatment visit, and every 3 months after the End-of-Treatment visit until disease progression is observed.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start18 Dec 2021
- Primary completion14 Apr 2023
- Study completion14 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Pancreatic Cancer Stage IVStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- CanBas Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04953962
- Sponsor's protocol ID
- CBP21-01
- Status last verified
- Aug 2023
- First submitted
- 29 Jun 2021
- Last updated
- 15 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mine N, Yamamoto S, Kufe DW, Von Hoff DD, Kawabe T. Activation of Nrf2 pathways correlates with resistance of NSCLC cell lines to CBP501 in vitro. Mol Cancer Ther. 2014 Sep;13(9):2215-25. doi: 10.1158/1535-7163.MCT-13-0808. Epub 2014 Jul 22.
PubMed 25053821Krug LM, Wozniak AJ, Kindler HL, Feld R, Koczywas M, Morero JL, Rodriguez CP, Ross HJ, Bauman JE, Orlov SV, Ruckdeschel JC, Mita AC, Fein L, He X, Hall R, Kawabe T, Sharma S. Randomized phase II trial of pemetrexed/cisplatin with or without CBP501 in patients with advanced malignant pleural mesothelioma. Lung Cancer. 2014 Sep;85(3):429-34. doi: 10.1016/j.lungcan.2014.06.008. Epub 2014 Jul 5.
PubMed 25047675Matsumoto Y, Shindo Y, Takakusagi Y, Takakusagi K, Tsukuda S, Kusayanagi T, Sato H, Kawabe T, Sugawara F, Sakaguchi K. Screening of a library of T7 phage-displayed peptides identifies alphaC helix in 14-3-3 protein as a CBP501-binding site. Bioorg Med Chem. 2011 Dec 1;19(23):7049-56. doi: 10.1016/j.bmc.2011.10.004. Epub 2011 Oct 7.
PubMed 22032894Mine N, Yamamoto S, Saito N, Yamazaki S, Suda C, Ishigaki M, Kufe DW, Von Hoff DD, Kawabe T. CBP501-calmodulin binding contributes to sensitizing tumor cells to cisplatin and bleomycin. Mol Cancer Ther. 2011 Oct;10(10):1929-38. doi: 10.1158/1535-7163.MCT-10-1139. Epub 2011 Aug 10.
PubMed 21831962Shapiro GI, Tibes R, Gordon MS, Wong BY, Eder JP, Borad MJ, Mendelson DS, Vogelzang NJ, Bastos BR, Weiss GJ, Fernandez C, Sutherland W, Sato H, Pierceall WE, Weaver D, Slough S, Wasserman E, Kufe DW, Von Hoff D, Kawabe T, Sharma S. Phase I studies of CBP501, a G2 checkpoint abrogator, as monotherapy and in combination with cisplatin in patients with advanced solid tumors. Clin Cancer Res. 2011 May 15;17(10):3431-42. doi: 10.1158/1078-0432.CCR-10-2345. Epub 2011 Jan 10.
PubMed 21220472Sha SK, Sato T, Kobayashi H, Ishigaki M, Yamamoto S, Sato H, Takada A, Nakajyo S, Mochizuki Y, Friedman JM, Cheng FC, Okura T, Kimura R, Kufe DW, Vonhoff DD, Kawabe T. Cell cycle phenotype-based optimization of G2-abrogating peptides yields CBP501 with a unique mechanism of action at the G2 checkpoint. Mol Cancer Ther. 2007 Jan;6(1):147-53. doi: 10.1158/1535-7163.MCT-06-0371.
PubMed 17237275Enzler T, Nguyen A, Misleh J, Cline VJ, Johns M, Shumway N, Paulson S, Siegel R, Larson T, Messersmith W, Richards D, Chaves J, Pierce E, Zalupski M, Sahai V, Orr D, Ruste SA, Haun A, Kawabe T. A multicenter, randomized phase 2 study to establish combinations of CBP501, cisplatin and nivolumab for >/=3rd-line treatment of patients with advanced pancreatic adenocarcinoma. Eur J Cancer. 2024 Apr;201:113950. doi: 10.1016/j.ejca.2024.113950. Epub 2024 Feb 22.
PubMed 38422585
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Parallel Group, Phase 2 to Establish the Efficacy and Safety of Combinations of CBP501, Cisplatin, and Nivolumab for ≥3rd Line Treatment of Patients With Exocrine Pancreatic Cancer and WBC <10,000/mm3 at Screening
- ClinicalTrials.gov ID
- NCT04953962
- Acronym / sponsor ID
- CBP21-01
- Conditions
- Pancreatic Cancer Stage IV
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- CanBas Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Dec 2021 (actual)
- Primary completion
- 14 Apr 2023 (actual)
- Study completion
- 14 Apr 2023 (actual)
- First posted
- 8 Jul 2021 (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.
Multicenter, randomized, open-label, parallel group phase 2 study to assess the efficacy and tolerance of four combinations of CBP501, cisplatin, and nivolumab administered once every 21 days to patients with stage IV exocrine pancreatic cancer and WBC < 10,000/mm3 at screening.
Detailed description
Multicenter, randomized, open-label, parallel group phase 2 study to assess the efficacy and tolerance of four combinations of CBP501, cisplatin, and nivolumab administered once every 21 days to patients with stage IV exocrine pancreatic cancer and WBC < 10,000/mm3 at screening. Patients will be randomized 1:1:1:1 to the following four treatment groups, with randomization stratified by ECOG PS (0 vs 1) and liver metastasis (present vs absent):
- CBP501 25 mg/m2 + cisplatin 60 mg/m2 + nivolumab 240 mg
- CBP501 16 mg/m2 + cisplatin 60 mg/m2 + nivolumab 240 mg
- CBP501 25 mg/m2 + cisplatin 60 mg/m2
- Cisplatin 60 mg/m2 + nivolumab 240 mg No more than 4 cycles of combination therapy may be administered but patients who remain progression-free after 4 cycles may receive up to 6 additional cycle of single-agent nivolumab.
A Fleming two-stage design will be used. For each study arm, the null hypothesis that the true percentage of patients progression-free at 3 months is 10% will be tested against a one-sided alternative. In the first stage, 9 patients will be accrued to each study arm. In the first stage, if there are 1 or fewer patient progression-free at 3 months the study will be stopped for futility and if there are 4 or more patients progression-free at 3 months the study will stopped and the null hypothesis rejected. Otherwise, 14 additional patients will be accrued to the study arm for a total of 23. The null hypothesis will be rejected if 6 or more of 23 patients are progression-free at 3 months. This design yields a type I error rate of 2.5% and power of 80% when the true percentage of patients progression-free at 3 months is 35%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1: CBP501 (25) + Cisplatin + Nivolumab | Experimental | Drug: CBP501 (25), Drug: Cisplatin, Drug: NivolumabCBP501 25mg/m2 and Cisplatin 60mg/m2 will be administered simultaneously. Nivolumab 240mg will be administered following the completion of CBP501 and cisplatin infusions. |
| Arm 2: CBP501 (16) + Cisplatin + Nivolumab | Experimental | Drug: CBP501 (16), Drug: Cisplatin, Drug: NivolumabCBP501 16mg/m2 and Cisplatin 60mg/m2 will be administered simultaneously. Nivolumab 240mg will be administered following the completion of CBP501 and cisplatin infusions. |
| Arm 3: CBP501 (25) + Cisplatin | Experimental | Drug: CBP501 (25), Drug: CisplatinCBP501 25mg/m2 and Cisplatin 60mg/m2 will be administered simultaneously. |
| Arm 4: Cisplatin + Nivolumab | Experimental | Drug: Cisplatin, Drug: NivolumabCisplatin 60mg/m2 will be administered as infusion and then Nivolumab 240mg will be administered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Signed informed consent obtained prior to initiation of any study-specific procedures and treatment;
- Patients with pathologically confirmed stage IV exocrine pancreatic cancer who have received at least two lines of systemic therapy for metastatic disease. Up to 10 of prior lines of systemic therapy (including prior cisplatin), chemoradiotherapy, radiotherapy or investigational agents the patient has received are allowed in order to be eligible, as long as all eligibility criteria are met, with the exception that a patient must not have received more than two prior lines incorporating anti-PD-1, anti-PD-L1, or anti-CTLA-4 immune checkpoint blockade.
- Patients who have received prior anti-PD-1, anti-PD-L1, or anti-CTLA-4 immune checkpoint blockade therapy must have tolerated therapy with no evidence of grade 4 toxicity or an immune-related event (any grade) that required treatment discontinuation. Patients who experienced an endocrine related dysfunction are eligible, provided they are on stable hormone replacement therapy;
- Male or female patients aged ≥ 18 years at time of informed consent;
- ECOG Performance Status (PS) 0-1;
Key exclusion criteria (17 listed)
- Radiation therapy to >30% of bone marrow prior to study entry;
- Prior chemotherapy with nitrosoureas, prior mitomycin C cumulative dose ≥ 25 mg/m2, prior bone marrow transplant, or prior intensive chemotherapy with stem cell support;
- Presence of any serious concomitant systemic disorders incompatible with the study in the opinion of the investigator (e.g., uncontrolled congestive heart failure, active infection, etc.);
- Any previous history of another malignancy (other than cured basal cell or squamous cell carcinoma of the skin or cured in-situ carcinoma) within 5 years of study entry;
- Presence of any significant central nervous system (CNS) or psychiatric disorder(s) that would hamper the patient's compliance;
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 |
|---|---|---|
| CBP501 (16)Also: CBP50116 mg/m2 | Drug | Arm 2: CBP501 (16) + Cisplatin + Nivolumab |
| CBP501 (25)Also: CBP50125 mg/m2 | Drug | Arm 1: CBP501 (25) + Cisplatin + Nivolumab, Arm 3: CBP501 (25) + Cisplatin |
| CisplatinAlso: CDDP60mg/m2 | Drug | Arm 1: CBP501 (25) + Cisplatin + Nivolumab, Arm 2: CBP501 (16) + Cisplatin + Nivolumab, Arm 3: CBP501 (25) + Cisplatin, Arm 4: Cisplatin + Nivolumab |
| NivolumabAlso: Opdivo240 mg | Drug | Arm 1: CBP501 (25) + Cisplatin + Nivolumab, Arm 2: CBP501 (16) + Cisplatin + Nivolumab, Arm 4: Cisplatin + Nivolumab |
Primary outcome
Three-month progression free survival rate (3M PFSR)
Time frame: 3 months after treatment
Tumor assessment by RECIST v.1.1 criteria will be performed at screening, every 8 weeks starting after Cycle 1 Day 1, at the End-of-Treatment visit, and every 3 months after the End-of-Treatment visit until disease progression is observed.
6 secondary outcomes
Safety profiles of the combinations of CBP501, cisplatin, and nivolumab administered once every 21 days
Time frame: One year
Progression-free survival (PFS)
Time frame: one year
Confirmed and timepoint objective response rates (cORR/ORR)
Time frame: one year
Duration of responses (DoR)
Time frame: one year
disease control rate (DCR: CR + PR + SD ≥12 weeks)
Time frame: one year
Overall survival (OS)
Time frame: one year
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 15 Aug 2023.
- Background: PubMed 25053821Mine N, Yamamoto S, Kufe DW, Von Hoff DD, Kawabe T. Activation of Nrf2 pathways correlates with resistance of NSCLC cell lines to CBP501 in vitro. Mol Cancer Ther. 2014 Sep;13(9):2215-25. doi: 10.1158/1535-7163.MCT-13-0808. Epub 2014 Jul 22.
- Background: PubMed 25047675Krug LM, Wozniak AJ, Kindler HL, Feld R, Koczywas M, Morero JL, Rodriguez CP, Ross HJ, Bauman JE, Orlov SV, Ruckdeschel JC, Mita AC, Fein L, He X, Hall R, Kawabe T, Sharma S. Randomized phase II trial of pemetrexed/cisplatin with or without CBP501 in patients with advanced malignant pleural mesothelioma. Lung Cancer. 2014 Sep;85(3):429-34. doi: 10.1016/j.lungcan.2014.06.008. Epub 2014 Jul 5.
- Background: PubMed 22032894Matsumoto Y, Shindo Y, Takakusagi Y, Takakusagi K, Tsukuda S, Kusayanagi T, Sato H, Kawabe T, Sugawara F, Sakaguchi K. Screening of a library of T7 phage-displayed peptides identifies alphaC helix in 14-3-3 protein as a CBP501-binding site. Bioorg Med Chem. 2011 Dec 1;19(23):7049-56. doi: 10.1016/j.bmc.2011.10.004. Epub 2011 Oct 7.
- Background: PubMed 21831962Mine N, Yamamoto S, Saito N, Yamazaki S, Suda C, Ishigaki M, Kufe DW, Von Hoff DD, Kawabe T. CBP501-calmodulin binding contributes to sensitizing tumor cells to cisplatin and bleomycin. Mol Cancer Ther. 2011 Oct;10(10):1929-38. doi: 10.1158/1535-7163.MCT-10-1139. Epub 2011 Aug 10.
- Background: PubMed 21220472Shapiro GI, Tibes R, Gordon MS, Wong BY, Eder JP, Borad MJ, Mendelson DS, Vogelzang NJ, Bastos BR, Weiss GJ, Fernandez C, Sutherland W, Sato H, Pierceall WE, Weaver D, Slough S, Wasserman E, Kufe DW, Von Hoff D, Kawabe T, Sharma S. Phase I studies of CBP501, a G2 checkpoint abrogator, as monotherapy and in combination with cisplatin in patients with advanced solid tumors. Clin Cancer Res. 2011 May 15;17(10):3431-42. doi: 10.1158/1078-0432.CCR-10-2345. Epub 2011 Jan 10.
- Background: PubMed 17237275Sha SK, Sato T, Kobayashi H, Ishigaki M, Yamamoto S, Sato H, Takada A, Nakajyo S, Mochizuki Y, Friedman JM, Cheng FC, Okura T, Kimura R, Kufe DW, Vonhoff DD, Kawabe T. Cell cycle phenotype-based optimization of G2-abrogating peptides yields CBP501 with a unique mechanism of action at the G2 checkpoint. Mol Cancer Ther. 2007 Jan;6(1):147-53. doi: 10.1158/1535-7163.MCT-06-0371.
- Derived from this study: PubMed 38422585Enzler T, Nguyen A, Misleh J, Cline VJ, Johns M, Shumway N, Paulson S, Siegel R, Larson T, Messersmith W, Richards D, Chaves J, Pierce E, Zalupski M, Sahai V, Orr D, Ruste SA, Haun A, Kawabe T. A multicenter, randomized phase 2 study to establish combinations of CBP501, cisplatin and nivolumab for >/=3rd-line treatment of patients with advanced pancreatic adenocarcinoma. Eur J Cancer. 2024 Apr;201:113950. doi: 10.1016/j.ejca.2024.113950. Epub 2024 Feb 22.
- 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.
20 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 CBP501 (16), CBP501 (25) and Cisplatin in people with Pancreatic Cancer Stage IV, run by CanBas Co. Ltd. at 20 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 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 15 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 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?
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?
Three-month progression free survival rate (3M PFSR) (time frame: 3 months after treatment). 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 NCT04953962, which also lists 7 linked publications.
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 15 Aug 2023.