Hodgkin Disease Clinical Trial
— CheckMate 744Official title:
Risk-based, Response-adapted, Phase II Open-label Trial of Nivolumab + Brentuximab Vedotin (N + Bv) for Children, Adolescents, and Young Adults With Relapsed/Refractory (R/R) CD30 + Classic Hodgkin Lymphoma (cHL) After Failure of First-line Therapy, Followed by Brentuximab + Bendamustine (Bv + B) for Participants With a Suboptimal Response (CheckMate 744: CHECKpoint Pathway and Nivolumab Clinical Trial Evaluation)
| Verified date | April 2024 |
| Source | Bristol-Myers Squibb |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to determine whether nivolumab plus brentuximab vedotin (followed by brentuximab vedotin plus bendamustine in patient with suboptimal response) is safe and effective in treating patients with Hodgkin's lymphoma (cHL). Eligible patients are children, adolescents, and young adults relapsed or refractory to first line.
| Status | Active, not recruiting |
| Enrollment | 72 |
| Est. completion date | November 10, 2024 |
| Est. primary completion date | June 25, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 5 Years to 30 Years |
| Eligibility | Inclusion Criteria: - Classic Hodgkin Lymphoma (cHL), relapsed or refractory - Minimal limitation on activities of daily living as measured by Karnofsky = 50 for participants > 16 years of age or Lansky = 50 for participants = 16 years of age. - One prior anti-cancer therapy that did not work Exclusion Criteria: - Active, known, or suspected autoimmune disease or infection - Active cerebral/meningeal disease related to the underlying malignancy - More than one line of anti-cancer therapy or no treatment at all - Received a stem cell transplant for Hodgkin Lymphoma and/or a solid organ transplant - Prior treatment with any drug that targets T cell co-stimulation pathways (such as checkpoint inhibitors) Other protocol defined inclusion/exclusion criteria apply |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Local Institution | Calgary | Alberta |
| Canada | The Montreal Children's Hospital of the MUHC | Montreal | Quebec |
| Canada | Local Institution - 0092 | Toronto | Ontario |
| Czechia | Klinika detske hematologie a onkologie | Praha 5 | |
| France | Local Institution - 0030 | Lille cedex | |
| France | CHU Lyon GH Est | Lyon Cedex 08 | |
| France | Local Institution - 0032 | Marseille | |
| France | Local Institution - 0028 | Nantes | |
| France | Local Institution - 0026 | Paris | |
| France | Local Institution - 0031 | Paris | |
| France | Local Institution - 0033 | Toulouse cedex 9 | |
| France | Local Institution - 0034 | Vandoeuvre lès Nancy | Meurthe-et-Moselle |
| France | Local Institution - 0027 | Villejuif | |
| Germany | Local Institution - 0056 | Berlin | |
| Germany | Local Institution - 0055 | Giessen | |
| Germany | Local Institution - 0057 | Hannover | |
| Germany | Local Institution - 0102 | Muenchen | |
| Ireland | Local Institution - 0017 | Dublin | |
| Italy | Local Institution - 0024 | Aviano (PN) | |
| Italy | Local Institution - 0020 | Bologna | |
| Italy | Irccs Istituto G. Gaslini | Genova | |
| Italy | Local Institution - 0019 | Monza (mb) | |
| Italy | Local Institution - 0023 | Napoli | |
| Italy | Local Institution - 0022 | Roma | |
| Netherlands | Local Institution - 0001 | Rotterdam | |
| Netherlands | Local Institution - 0006 | Utrecht | |
| Poland | Local Institution | Gdansk | |
| Poland | Local Institution | Krakow | |
| Spain | Local Institution - 0082 | Barcelona | |
| Spain | Local Institution | Madrid | |
| United Kingdom | Local Institution | Birmingham | |
| United Kingdom | Local Institution | Glasgow | |
| United Kingdom | Local Institution | Leeds | Yorkshire |
| United Kingdom | Local Institution - 0035 | Leeds | North Yorkshire |
| United Kingdom | Local Institution - 0002 | London | |
| United Kingdom | Local Institution - 0012 | Manchester | |
| United States | Children's Healthcare Of Atlanta | Atlanta | Georgia |
| United States | Childrens Hospital of Colorado | Aurora | Colorado |
| United States | Local Institution - 0042 | Austin | Texas |
| United States | Local Institution - 0070 | Baltimore | Maryland |
| United States | Children's Hospital of Alabama | Birmingham | Alabama |
| United States | Dana Farber Cancer Institute. | Boston | Massachusetts |
| United States | Local Institution - 0068 | Buffalo | New York |
| United States | Local Institution | Chapel Hill | North Carolina |
| United States | Carolinas Medical Center | Charlotte | North Carolina |
| United States | Cincinnati Children'S Hospital Medical Center | Cincinnati | Ohio |
| United States | Local Institution - 0089 | Columbus | Ohio |
| United States | Local Institution - 0071 | Dallas | Texas |
| United States | Local Institution - 0097 | Detroit | Michigan |
| United States | Local Institution - 0067 | Hackensack | New Jersey |
| United States | Local Institution - 0090 | Hershey | Pennsylvania |
| United States | Baylor College Of Medicine | Houston | Texas |
| United States | University Of Iowa | Iowa City | Iowa |
| United States | Local Institution - 0049 | Jackson | Mississippi |
| United States | Local Institution - 0062 | Jacksonville | Florida |
| United States | Local Institution - 0085 | Kansas City | Missouri |
| United States | Nevada Cancer Research Foundation | Las Vegas | Nevada |
| United States | Loma Linda University Cancer Center | Loma Linda | California |
| United States | Valley Children's Hospital | Madera | California |
| United States | Local Institution - 0065 | Milwaukee | Wisconsin |
| United States | Vanderbilt University | Nashville | Tennessee |
| United States | Local Institution - 0047 | New Brunswick | New Jersey |
| United States | Smilow Cancer Hospital At Yale New Haven Hospital | New Haven | Connecticut |
| United States | Children'S Hosp-Kings Daughter | Norfolk | Virginia |
| United States | Children'S Hospital & Research Center At Oakland | Oakland | California |
| United States | University Of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma |
| United States | Children'S Hospital Of Orange County | Orange | California |
| United States | Lucile Packard Children'S Research Hospital/Stanford Univ | Palo Alto | California |
| United States | Childrens Hospital Of Philadelphia | Philadelphia | Pennsylvania |
| United States | Phoenix Children'S Hospital | Phoenix | Arizona |
| United States | Childrens Hospital Of Pittsburgh Of Upmc | Pittsburgh | Pennsylvania |
| United States | Virginia Commonwealth University | Richmond | Virginia |
| United States | Washington University School Of Medicine | Saint Louis | Missouri |
| United States | Local Institution - 0069 | Saint Petersburg | Florida |
| United States | Primary Children's Hospital | Salt Lake City | Utah |
| United States | Local Institution - 0091 | San Diego | California |
| United States | Local Institution - 0048 | Seattle | Washington |
| United States | Children'S National Medical Center | Washington | District of Columbia |
| United States | Nemours / A. I. duPont Hospital for Children | Wilmington | Delaware |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb | Seagen Inc. |
United States, Canada, Czechia, France, Germany, Ireland, Italy, Netherlands, Poland, Spain, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Event Free Survival (EFS) | Low Risk Group. Based on blinded independent central review (BICR) | Up to 5 years | |
| Primary | Complete Metabolic Response (CMR) rate prior to HDCT/ASCT | Standard Risk Group. This is the rate prior to high-dose chemotherapy followed by autologous stem cell transplant (HDCT/ASCT) based on the blinded independent central review (BICR) using Lugano 2014 criteria. | Up to 5 years | |
| Primary | Complete Metabolic Response (CMR) rate at any time prior to radiation therapy | Low Risk Group. The CMR rate is defined as the proportion of all response-evaluable participants who, assessed by the BICR, achieve best response of CMR using Lugano 2014 criteria. | Up to 5 years | |
| Secondary | Overall Response Rate (ORR) after 4 cycles of nivolumab + brentuximab vedotin treatment | Based on blinded independent central review (BICR) | Up to 12 weeks | |
| Secondary | Progression Free Survival Rate (PFSR) | Based on the blinded independent central review (BICR) | Up to 5 years | |
| Secondary | Duration of Response (DOR) | Based on the blinded independent central review (BICR) | Up to 5 years | |
| Secondary | Incidence of serious and non-serious adverse events of nivolumab (BMS-936558) and brentuximab when given in combination. | measured by number of patients | Up to 5 years | |
| Secondary | Incidence of clinically significant abnormalities in general laboratory tests of nivolumab (BMS-936558) and brentuximab when given in combination. | Hematology, Chemistry and Urinalysis | Up to 5 years | |
| Secondary | Incidence of clinically significant vital sign measurements of nivolumab (BMS-936558) and brentuximab when given in combination. | Temperature, Blood Pressure and Heart Rate | Up to 5 years | |
| Secondary | Complete Metabolic Response (CMR) rate prior to HDCT/ASCT | Standard Risk Group. This is the rate prior to high-dose chemotherapy followed by autologous stem cell transplant (HDCT/ASCT) based on investigator assessments using Lugano 2014 criteria. | Up to 5 years | |
| Secondary | Complete Metabolic Response (CMR) rate at any time prior to radiation therapy | Low Risk Group. This is the rate prior to radiation therapy based on investigator assessments using Lugano 2014 criteria. | Up to 5 years | |
| Secondary | Event Free Survival (EFS) | Low Risk Group. Based on investigator assessments | Up to 5 years | |
| Secondary | Overall Response Rate (ORR) after 4 cycles of nivolumab + brentuximab vedotin treatment | Both Risk Groups. Based on investigator assessments | Up to 12 weeks | |
| Secondary | Progression Free Survival Rate (PFSR) | Both Risk Groups. Based on investigator assessments | Up to 5 years | |
| Secondary | Duration of Response (DOR) | Both Risk Groups. Based on investigator assessments | Up to 5 years |
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