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| ID | Type | Description | Link |
|---|---|---|---|
| MK-3475-C11 | Other Identifier | MSD | |
| KEYNOTE-C11 | Other Identifier | MSD | |
| 2022-501615-14-00 | Registry Identifier | EU CT | |
| U1111-1281-5347 | Registry Identifier | UTN | |
| 2021-001244-95 | EudraCT Number |
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The purpose of this study is to evaluate the safety and efficacy of pembrolizumab (MK-3475) monotherapy, followed by chemotherapy, followed by pembrolizumab consolidation. The primary hypothesis of the study is that the complete response (CR) rate at the end of study intervention according to Lugano 2014 response criteria is higher than conventional chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pembrolizumab Monotherapy + AVD Chemotherapy/escBEACOPP Chemotherapy + Pembrolizumab Consolidation | Experimental | After completing Positron Emission Tomography (PET) scan 1 during eligibility screening, participants received pembrolizumab monotherapy intravenous (IV) for three 3-week cycles followed by PET scan 2. Participants next received 2 phases of chemotherapy. In chemotherapy phase 1, all participants received doxorubicin in combination with vinblastine & dacarbazine (AVD) IV for two 4-week cycles followed by PET scan 3. In chemotherapy phase 2, participants who were PET scan 3 negative, or positive and age ≥60 years, received up to 4 additional cycles of AVD IV, while participants who were PET scan 3 positive and age <60 years received up to four 3-week cycles of escalated bleomycin in combination with etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, & prednisone (escBEACOPP) IV. All participants then received pembrolizumab consolidation IV for four 6-week cycles followed by a final PET scan. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pembrolizumab | Biological | 200 mg IV administered on Day 1 of each 3-week cycle for 3 cycles during pembrolizumab monotherapy. 400 mg IV administered on Day 1 of each 6-week cycle for 4 cycles as pembrolizumab consolidation. |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response (CR) Rate at the End of Study Intervention as Assessed by Blinded Independent Central Review (BICR) Per Lugano 2014 Response Criteria | CR rate was assessed by BICR using Computed Tomography (CT) and PET scan according to Lugano 2014 response criteria (Cheson, B.D. et al, Journal of Clinical Oncology, 2014). At each timepoint, CR was determined by combining the anatomic response, metabolic response, and clinical data. The criteria for CR included complete metabolic (no/minimal 2-fluorodeoxyglucose [FDG] uptake) and radiologic response (target lesions regress to ≤1.5 cm in longest transverse diameter of a lesion) and no new lesions. Per protocol, participants who discontinued study intervention during pembrolizumab monotherapy, chemotherapy, or pembrolizumab consolidation, or are lost to follow-up, or receive any new non-study anticancer therapy prior to end of treatment were classified as non-responders. The percentage of participants who had CR after the completion of pembrolizumab consolidation is presented. | Up to approximately 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| CR Rate at the End of Study Intervention as Assessed by Investigator Per Lugano 2014 Response Criteria | CR rate was assessed by the investigator using CT and PET scan according to Lugano 2014 response criteria (Cheson, B.D. et al, Journal of Clinical Oncology, 2014). At each timepoint, CR was determined by combining the anatomic response, metabolic response, and clinical data. The criteria for CR included complete metabolic (no/minimal FDG uptake) and radiologic response (target lesions regress to ≤1.5 cm in longest transverse diameter of a lesion) and no new lesions. Per protocol, participants who discontinued study intervention during pembrolizumab monotherapy, chemotherapy, or pembrolizumab consolidation, or are lost to follow-up, or receive any new non-study anticancer therapy prior to end of treatment were classified as non-responders. The percentage of participants who had CR after the completion of pembrolizumab consolidation is presented. |
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Inclusion Criteria:
The main inclusion criteria include, but are not limited to the following:
Exclusion Criteria:
The main exclusion criteria include, but are not limited to the following:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Joseph Heritage Healthcare-Oncology ( Site 0004) | Fullerton | California | 92835 | United States | ||
| Stanford Cancer Center ( Site 0023) |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
| Plain Language Summary | View source |
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146 participants were allocated to the treatment arm and received sequential treatments beginning with pembrolizumab monotherapy, followed by chemotherapy (phases 1 and 2), and finishing with pembrolizumab consolidation.
Per protocol, efficacy analysis was planned and conducted on the treatment arm of participants that received these sequential treatments. Safety outcome measures were analyzed based on the individual study treatment received by the participant at the time of the event.
Male or female participants with newly diagnosed early unfavorable or advanced-stage classical Hodgkin Lymphoma (cHL), who were at least 18 years old, were enrolled in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pembrolizumab Monotherapy + AVD Chemotherapy/escBEACOPP Chemotherapy + Pembrolizumab Consolidation | After completing Positron Emission Tomography (PET) scan 1 during eligibility screening, participants received pembrolizumab monotherapy intravenous (IV) for three 3-week cycles followed by PET scan 2. Participants next received 2 phases of chemotherapy. In chemotherapy phase 1, all participants received doxorubicin in combination with vinblastine & dacarbazine (AVD) IV for two 4-week cycles followed by PET scan 3. In chemotherapy phase 2, participants who were PET scan 3 negative, or positive and age ≥60 years, received up to 4 additional cycles of AVD IV, while participants who were PET scan 3 positive and age <60 years received up to four 3-week cycles of escalated bleomycin in combination with etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, & prednisone (escBEACOPP) IV. All participants then received pembrolizumab consolidation IV for four 6-week cycles followed by a final PET scan. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 15, 2023 |
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| Doxorubicin | Drug | 25 mg/m^2 IV administered as part of AVD chemotherapy on Days 1 and 15 of each 4-week cycle for 2 cycles in all participants after PET scan 2 and up to 4 additional cycles after PET scan 3 (participants who are PET scan 3 negative, or positive and ≥60 years of age). 35 mg/m^2 IV administered as part of escBEACOPP chemotherapy on Day 1 of each 3-week cycle for up to 4 cycles after PET scan 3 (participants who are PET scan 3 positive, <60 years of age). |
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| Vinblastine | Drug | 6 mg/m^2 IV administered as part of AVD chemotherapy on Days 1 and 15 of each 4-week cycle for 2 cycles after PET scan 2 (all participants) and up to 4 additional cycles after PET scan 3 (participants who are PET scan 3 negative, or positive and ≥60 years of age). |
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| Dacarbazine | Drug | 375 mg/m^2 IV administered as part of AVD chemotherapy on Days 1 and 15 of each 4-week cycle for 2 cycles after PET scan 2 (all participants) and up to 4 additional cycles after PET scan 3 (participants who are PET scan 3 negative, or positive and ≥60 years of age). |
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| Bleomycin | Drug | 10 units/m^2 IV administered as part of escBEACOPP chemotherapy on Day 8 of each 3-week cycle for up to 4 cycles after PET scan 3 (participants who are PET scan 3 positive and <60 years of age). |
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| Etoposide | Drug | 200 mg/m^2 IV administered as part of escBEACOPP chemotherapy on Days 1-3 of each 3-week cycle for up to 4 cycles after PET scan 3 (participants who are PET scan 3 positive and <60 years of age). |
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| Cyclophosphamide | Drug | 1250 mg/m^2 IV administered as part of escBEACOPP chemotherapy on Day 1 of each 3-week cycle for up to 4 cycles after PET scan 3 (participants who are PET scan 3 positive and <60 years of age). |
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| Vincristine | Drug | 1.4 mg/m^2 IV administered as part of escBEACOPP chemotherapy on Day 8 of each 3-week cycle for up to 4 cycles after PET scan 3 (participants who are PET scan 3 positive and <60 years of age). |
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| Procarbazine | Drug | 100 mg/m^2 orally (PO) administered as part of escBEACOPP chemotherapy on Days 1-7 of each 3-week cycle for up to 4 cycles after PET scan 3 (participants who are PET scan 3 positive and <60 years of age). |
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| Prednisone | Drug | 40 mg/m^2 PO administered as part of escBEACOPP chemotherapy on Days 1-14 of each 3-week cycle for up to 4 cycles after PET scan 3 (participants who are PET scan 3 positive and <60 years of age). |
|
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| Up to approximately 31 months |
| Duration of Complete Response (DurCR) as Assessed by BICR Per Lugano 2014 Response Criteria | DurCR was defined as the time from CR to progressive disease (PD) or death due to any cause, whichever came first. CR was assessed by BICR using CT and PET scan according to Lugano 2014 response criteria (Cheson, B.D. et al, Journal of Clinical Oncology, 2014). At each timepoint, CR was determined by combining the anatomic response, metabolic response, and clinical data. The criteria for CR included complete metabolic (no/minimal FDG uptake) and radiologic response (target lesions regress to ≤1.5 cm in longest transverse diameter of a lesion) and no new lesions. PD was defined as uptake moderately or markedly higher than the liver and/or new lesions. DurCR was analyzed by the Kaplan-Meier method for censored data and is presented for participants who demonstrated CR. | Up to approximately 31 months |
| Rate of PET Negativity Assessed by BICR According to the FDG-PET 5-point Scale After Administration of Pembrolizumab Monotherapy (PET Scan 2) | The rate of PET negativity was defined as the percentage of participants considered negative on the FDG-PET 5-point scale, as assessed by BICR according to Lugano 2014 response criteria (Cheson, B.D. et al, Journal of Clinical Oncology, 2014). Participants were assigned a single score on the FDG-PET 5-point scale measuring FDG uptake (1 = no uptake above background, 2 = uptake above background but ≤ mediastinum, 3 = uptake > mediastinum but ≤ liver, 4 = uptake moderately > liver, 5 = uptake markedly > liver or new FDG-positive lesions). Higher scores corresponded to greater uptake (greater disease). FDG-PET 5-point scale scores of 1, 2, and 3 were considered negative and scores of 4 and 5 were considered positive. The percentage of participants who were assessed as negative at PET scan 2, after completion of 3 cycles of pembrolizumab monotherapy, is presented. | Up to approximately 10 weeks |
| Rate of PET Negativity Assessed by BICR According to the FDG-PET 5-point Scale After Administration of Pembrolizumab Monotherapy and AVD Chemotherapy (PET Scan 3) | The rate of PET negativity was defined as the percentage of participants considered negative on the FDG-PET 5-point scale, as assessed by BICR according to Lugano 2014 response criteria (Cheson, B.D. et al, Journal of Clinical Oncology, 2014). Participants were assigned a single score on the FDG-PET 5-point scale measuring FDG uptake (1 = no uptake above background, 2 = uptake above background but ≤ mediastinum, 3 = uptake > mediastinum but ≤ liver, 4 = uptake moderately > liver, 5 = uptake markedly > liver or new FDG-positive lesions). Higher scores corresponded to greater uptake (greater disease). FDG-PET 5-point scale scores of 1, 2, and 3 were considered negative and scores of 4 and 5 were considered positive. The percentage of participants who were assessed as negative at PET scan 3, after completion of 3 cycles of pembrolizumab monotherapy and phase 1 AVD chemotherapy (2 AVD cycles), is presented. | Up to approximately 5 months |
| Number of Participants Who Experienced an Adverse Event (AE) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Per protocol, collection and reporting of AEs was based on the study treatment received by the participant (pembrolizumab, AVD chemotherapy, or escBEACOPP chemotherapy) at the time of the event. The number of participants who experienced an AE is reported. | Up to approximately 31 months |
| Number of Participants Who Discontinued Study Treatment Due to an AE | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Per protocol, collection and reporting of AEs was based on the study treatment received by the participant (pembrolizumab, AVD chemotherapy, or escBEACOPP chemotherapy) at the time of the event. The number of participants who discontinued study intervention due to an AE is reported. | Up to approximately 17 months |
| Palo Alto |
| California |
| 94304 |
| United States |
| Northwestern Memorial Hospital ( Site 0002) | Chicago | Illinois | 60611 | United States |
| OptumCare Cancer Care-Research Department ( Site 0005) | Las Vegas | Nevada | 89102 | United States |
| University of Tennessee Medical Center-Cancer Institute ( Site 0006) | Knoxville | Tennessee | 37920 | United States |
| Texas Oncology-Plano East ( Site 0020) | Plano | Texas | 75075 | United States |
| Liverpool Hospital-Haematology ( Site 0906) | Liverpool | New South Wales | 2170 | Australia |
| Mater Misericordiae Limited ( Site 0904) | Brisbane | Queensland | 4101 | Australia |
| Princess Alexandra Hospital-Division of Cancer Services Trials Unit ( Site 0907) | Woolloongabba | Queensland | 4102 | Australia |
| Monash Health-Haematology Research ( Site 0908) | Clayton | Victoria | 3168 | Australia |
| Peter MacCallum Cancer Centre ( Site 0905) | Melbourne | Victoria | 3000 | Australia |
| Cross Cancer Institute ( Site 0207) | Edmonton | Alberta | T6G 1Z2 | Canada |
| Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre ( Site 0205) | Greenfield Park | Quebec | J4V 2H1 | Canada |
| Jewish General Hospital ( Site 0200) | Montreal | Quebec | H3T 1E2 | Canada |
| McGill University Health Centre ( Site 0209) | Montreal | Quebec | H4A 3J1 | Canada |
| Hopital du Sacre-Coeur de Montreal ( Site 0206) | Montreal | Quebec | H4J 1C5 | Canada |
| Centro Investigación del Cáncer James Lind ( Site 1200) | Temuco | Araucania | 4780000 | Chile |
| Instituto Nacional del Cancer ( Site 1205) | Chile | Region M. de Santiago | 8380455 | Chile |
| FALP-UIDO ( Site 1202) | Santiago | Region M. de Santiago | 6900941 | Chile |
| Clínica Alemana de Santiago ( Site 1206) | Santiago | Region M. de Santiago | 8320325 | Chile |
| Pontificia Universidad Catolica de Chile-Hemato-Oncology ( Site 1204) | Santiago | Region M. de Santiago | 8330032 | Chile |
| CHU Bordeaux Haut-Leveque ( Site 1505) | Pessac | Aquitaine | 33600 | France |
| Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou-haematology ( Site 1502) | Rennes | Brittany Region | 35033 | France |
| Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand ( Site 1504) | Dijon | Cote-d Or | 21000 | France |
| centre hospitalier lyon sud-Service Hématologie ( Site 1501) | Pierre-Bénite | Rhone | 69310 | France |
| Centre de Lutte Contre le Cancer - Centre Henri Becquerel Normandie Rouen-Service d'Hématologie ( Si | Rouen | Seine-Maritime | 76000 | France |
| Rambam Health Care Campus ( Site 1907) | Haifa | 3109601 | Israel |
| Bnai Zion Medical Center-Hematology ( Site 1909) | Haifa | 3339419 | Israel |
| Hadassah Medical Center ( Site 1901) | Jerusalem | 9112001 | Israel |
| Sheba Medical Center-Hemato Oncology ( Site 1904) | Ramat Gan | 5265601 | Israel |
| ZIV Medical Center ( Site 1908) | Safed | 1311001 | Israel |
| Sourasky Medical Center ( Site 1905) | Tel Aviv | 6423906 | Israel |
| Azienda Ospedaliera Spedali Civili di Brescia-Hemathology ( Site 1801) | Brescia | Lombardy | 25123 | Italy |
| ASST Grande Ospedale Metropolitano Niguarda ( Site 1803) | Milan | Milano | Italy |
| Policlinico S. Orsola- Malpighi-Istituto di Ematologia L. e A. Seragnoli ( Site 1800) | Bologna | 40138 | Italy |
| Fondazione Policlinico Universitario Agostino Gemelli-ISTITUTO DI EMATOLOGIA ( Site 1804) | Roma | 00168 | Italy |
| Klinika Hematologii - Instytut Hematologii i Transfuzjologii-Klinika Hematologii ( Site 0402) | Warsaw | Masovian Voivodeship | 02-776 | Poland |
| Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( | Warsaw | Masovian Voivodeship | 02-781 | Poland |
| Szpital Wojewódzki w Opolu-Hematology Department ( Site 0401) | Opole | Opole Voivodeship | 46-020 | Poland |
| Uniwersyteckie Centrum Kliniczne-Klinika Hematologii i Transplantologii ( Site 0403) | Gdansk | Pomeranian Voivodeship | 80-952 | Poland |
| Moscow City Clinical Hospital S.P. Botkin ( Site 0702) | Moscow | Moscow | 125284 | Russia |
| First Pavlov State Medical University of Saint Petersburg-Raisa Gorbacheva Memorial Institut for Pe | Saint Petersburg | Sankt-Peterburg | 197022 | Russia |
| Almazov National Medical Research Centre ( Site 0704) | Saint Petersburg | Sankt-Peterburg | 197341 | Russia |
| Instituto Catalan de Oncologia - Hospital Duran i Reynals-Haematology Department ( Site 1031) | L'Hospitalet Del Llobregat | Barcelona | 08908 | Spain |
| Hospital Universitario 12 de Octubre ( Site 1032) | Madrid | 28041 | Spain |
| Dokuz Eylül Üniversitesi ( Site 5002) | Balçova | İzmir | Turkey (Türkiye) |
| Ankara University Hospital Cebeci-hematology ( Site 5000) | Ankara | 06100 | Turkey (Türkiye) |
| Vehbi Koc Vakfi - Amerikan Hastanesi ( Site 5001) | Istanbul | 34365 | Turkey (Türkiye) |
| Received ≥1 Dose of Pembrolizumab |
|
| Received at ≥1 Dose of AVD Chemotherapy |
|
| Received at ≥1 Dose of escBEACOPP Chemotherapy |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
The analysis population consisted of all participants who received at least 1 dose of pembrolizumab
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| ID | Title | Description |
|---|---|---|
| BG000 | Pembrolizumab Monotherapy + AVD Chemotherapy/escBEACOPP Chemotherapy + Pembrolizumab Consolidation | After completing PET scan 1 during eligibility screening, participants received pembrolizumab monotherapy IV for three 3-week cycles followed by PET scan 2. Participants next received 2 phases of chemotherapy. In chemotherapy phase 1, all participants received AVD IV for two 4-week cycles followed by PET scan 3. In chemotherapy phase 2, participants who were PET scan 3 negative, or positive and age ≥60 years, received up to 4 additional cycles of AVD IV, while participants who were PET scan 3 positive and age <60 years received up to four 3-week cycles of escBEACOPP IV. All participants then received pembrolizumab consolidation IV for four 6-week cycles followed by a final PET scan. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Complete Response (CR) Rate at the End of Study Intervention as Assessed by Blinded Independent Central Review (BICR) Per Lugano 2014 Response Criteria | CR rate was assessed by BICR using Computed Tomography (CT) and PET scan according to Lugano 2014 response criteria (Cheson, B.D. et al, Journal of Clinical Oncology, 2014). At each timepoint, CR was determined by combining the anatomic response, metabolic response, and clinical data. The criteria for CR included complete metabolic (no/minimal 2-fluorodeoxyglucose [FDG] uptake) and radiologic response (target lesions regress to ≤1.5 cm in longest transverse diameter of a lesion) and no new lesions. Per protocol, participants who discontinued study intervention during pembrolizumab monotherapy, chemotherapy, or pembrolizumab consolidation, or are lost to follow-up, or receive any new non-study anticancer therapy prior to end of treatment were classified as non-responders. The percentage of participants who had CR after the completion of pembrolizumab consolidation is presented. | The analysis population consisted of all participants who received at least 1 dose of pembrolizumab. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to approximately 24 months |
|
|
| |||||||||||||||||||||||||
| Secondary | CR Rate at the End of Study Intervention as Assessed by Investigator Per Lugano 2014 Response Criteria | CR rate was assessed by the investigator using CT and PET scan according to Lugano 2014 response criteria (Cheson, B.D. et al, Journal of Clinical Oncology, 2014). At each timepoint, CR was determined by combining the anatomic response, metabolic response, and clinical data. The criteria for CR included complete metabolic (no/minimal FDG uptake) and radiologic response (target lesions regress to ≤1.5 cm in longest transverse diameter of a lesion) and no new lesions. Per protocol, participants who discontinued study intervention during pembrolizumab monotherapy, chemotherapy, or pembrolizumab consolidation, or are lost to follow-up, or receive any new non-study anticancer therapy prior to end of treatment were classified as non-responders. The percentage of participants who had CR after the completion of pembrolizumab consolidation is presented. | The analysis population consisted of all participants who received at least 1 dose of pembrolizumab. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to approximately 31 months |
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| Secondary | Duration of Complete Response (DurCR) as Assessed by BICR Per Lugano 2014 Response Criteria | DurCR was defined as the time from CR to progressive disease (PD) or death due to any cause, whichever came first. CR was assessed by BICR using CT and PET scan according to Lugano 2014 response criteria (Cheson, B.D. et al, Journal of Clinical Oncology, 2014). At each timepoint, CR was determined by combining the anatomic response, metabolic response, and clinical data. The criteria for CR included complete metabolic (no/minimal FDG uptake) and radiologic response (target lesions regress to ≤1.5 cm in longest transverse diameter of a lesion) and no new lesions. PD was defined as uptake moderately or markedly higher than the liver and/or new lesions. DurCR was analyzed by the Kaplan-Meier method for censored data and is presented for participants who demonstrated CR. | The analysis population consisted of all participants who received at least 1 dose of pembrolizumab and who had achieved CR. DurCR data was censored on the date of the last disease assessment documenting absence of PD for participants who do not have progression and are still on study at the time of an analysis, are given antitumor treatment other than the study treatment, or are removed from study prior to documentation of tumor progression. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 31 months |
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| Secondary | Rate of PET Negativity Assessed by BICR According to the FDG-PET 5-point Scale After Administration of Pembrolizumab Monotherapy (PET Scan 2) | The rate of PET negativity was defined as the percentage of participants considered negative on the FDG-PET 5-point scale, as assessed by BICR according to Lugano 2014 response criteria (Cheson, B.D. et al, Journal of Clinical Oncology, 2014). Participants were assigned a single score on the FDG-PET 5-point scale measuring FDG uptake (1 = no uptake above background, 2 = uptake above background but ≤ mediastinum, 3 = uptake > mediastinum but ≤ liver, 4 = uptake moderately > liver, 5 = uptake markedly > liver or new FDG-positive lesions). Higher scores corresponded to greater uptake (greater disease). FDG-PET 5-point scale scores of 1, 2, and 3 were considered negative and scores of 4 and 5 were considered positive. The percentage of participants who were assessed as negative at PET scan 2, after completion of 3 cycles of pembrolizumab monotherapy, is presented. | The analysis population consisted of all participants who had completed 3 cycles of pembrolizumab monotherapy. | Posted | Number | Percentage of Participants | Up to approximately 10 weeks |
|
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| Secondary | Rate of PET Negativity Assessed by BICR According to the FDG-PET 5-point Scale After Administration of Pembrolizumab Monotherapy and AVD Chemotherapy (PET Scan 3) | The rate of PET negativity was defined as the percentage of participants considered negative on the FDG-PET 5-point scale, as assessed by BICR according to Lugano 2014 response criteria (Cheson, B.D. et al, Journal of Clinical Oncology, 2014). Participants were assigned a single score on the FDG-PET 5-point scale measuring FDG uptake (1 = no uptake above background, 2 = uptake above background but ≤ mediastinum, 3 = uptake > mediastinum but ≤ liver, 4 = uptake moderately > liver, 5 = uptake markedly > liver or new FDG-positive lesions). Higher scores corresponded to greater uptake (greater disease). FDG-PET 5-point scale scores of 1, 2, and 3 were considered negative and scores of 4 and 5 were considered positive. The percentage of participants who were assessed as negative at PET scan 3, after completion of 3 cycles of pembrolizumab monotherapy and phase 1 AVD chemotherapy (2 AVD cycles), is presented. | The analysis population consisted of all participants who had completed 3 cycles of pembrolizumab monotherapy and phase 1 AVD chemotherapy (2 AVD cycles). | Posted | Number | Percentage of Participants | Up to approximately 5 months |
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Experienced an Adverse Event (AE) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Per protocol, collection and reporting of AEs was based on the study treatment received by the participant (pembrolizumab, AVD chemotherapy, or escBEACOPP chemotherapy) at the time of the event. The number of participants who experienced an AE is reported. | The analysis population consisted of all participants who received at least 1 dose of study intervention. Per protocol, analysis was based on the study treatment received by the participant (pembrolizumab, AVD chemotherapy, or escBEACOPP chemotherapy) at the time of the event. | Posted | Count of Participants | Participants | Up to approximately 31 months |
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Discontinued Study Treatment Due to an AE | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Per protocol, collection and reporting of AEs was based on the study treatment received by the participant (pembrolizumab, AVD chemotherapy, or escBEACOPP chemotherapy) at the time of the event. The number of participants who discontinued study intervention due to an AE is reported. | The analysis population consisted of all participants who received at least 1 dose of study intervention. Per protocol, analysis was based on the study treatment received by the participant (pembrolizumab, AVD chemotherapy, or escBEACOPP chemotherapy) at the time of the event. | Posted | Count of Participants | Participants | Up to approximately 17 months |
|
Up to approximately 31 months
All-Cause Mortality included all allocated participants. Serious and Other AEs included all participants who received ≥1 dose of study intervention. As pre-specified by the protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" that were not related to study drug were excluded as AEs. Per protocol, reporting of All-Cause Mortality and AEs was based on the individual study treatment received by the participant at the time of the event.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pembrolizumab Monotherapy and Consolidation | Participants received pembrolizumab monotherapy IV for three 3-week cycles followed by PET scan 2. Participants also received pembrolizumab consolidation IV for four 6-week cycles followed by a final PET scan. Per protocol, collection and reporting of AEs was based on the individual study treatment received by the participant (i.e., pembrolizumab) at the time of the event. | 0 | 146 | 26 | 146 | 122 | 146 |
| EG001 | AVD Chemotherapy | In chemotherapy phase 1, participants received AVD IV for two 4-week cycles followed by PET scan 3. In chemotherapy phase 2, participants who were PET scan 3 negative, or positive and age ≥60 years, received up to 4 additional cycles of AVD IV. Per protocol, collection and reporting of AEs was based on the individual study treatment received by the participant (i.e., AVD chemotherapy) at the time of the event. | 3 | 136 | 26 | 136 | 131 | 136 |
| EG002 | escBEACOPP Chemotherapy | In chemotherapy phase 2, participants who were PET scan 3 positive and age <60 years received up to four 3-week cycles of escBEACOPP IV. Per protocol, collection and reporting of AEs was based on the individual study treatment received by the participant (i.e., escBEACOPP chemotherapy) at the time of the event. | 0 | 17 | 6 | 17 | 17 | 17 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Immune-mediated hepatitis | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Campylobacter gastroenteritis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Device related sepsis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Meningitis aseptic | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Meningitis viral | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pseudomonas infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Rhinovirus infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Sialoadenitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Chest wall necrosis | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Immune-mediated encephalitis | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Erythema multiforme | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Eosinophilia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Salivary hypersecretion | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Blood bicarbonate decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Lactic acidosis | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
|
The results of this study may be published or presented at scientific meetings. The Sponsor will generally support publication of multicenter studies only in their entirety and not as individual site data. If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. Authorship will be determined by mutual agreement and in line with International Committee of Medical Journal Editors requirements.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme LLC | 1-800-672-6372 | ClinicalTrialsDisclosure@msd.com |
| May 23, 2025 |
| Prot_SAP_001.pdf |
| ID | Term |
|---|---|
| C565324 | Parkinson Disease 4, Autosomal Dominant Lewy Body |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C582435 | pembrolizumab |
| D004317 | Doxorubicin |
| C506643 | liposomal doxorubicin |
| D014747 | Vinblastine |
| D003606 | Dacarbazine |
| D001761 | Bleomycin |
| D005047 | Etoposide |
| C061400 | etoposide phosphate |
| D003520 | Cyclophosphamide |
| D014750 | Vincristine |
| D011344 | Procarbazine |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D014226 | Triazenes |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D005960 | Glucosides |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D001549 | Benzamides |
| D000577 | Amides |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
In chemotherapy phase 1, participants received AVD IV for two 4-week cycles followed by PET scan 3. In chemotherapy phase 2, participants who were PET scan 3 negative, or positive and age ≥60 years, received up to 4 additional cycles of AVD IV. Per protocol, collection and reporting of AEs was based on the individual study treatment received by the participant (i.e., AVD chemotherapy) at the time of the event. |
| OG002 | escBEACOPP Chemotherapy | In chemotherapy phase 2, participants who were PET scan 3 positive and age <60 years received up to four 3-week cycles of escBEACOPP IV. Per protocol, collection and reporting of AEs was based on the individual study treatment received by the participant (i.e., escBEACOPP chemotherapy) at the time of the event. |
|
|
| AVD Chemotherapy |
In chemotherapy phase 1, participants received AVD IV for two 4-week cycles followed by PET scan 3. In chemotherapy phase 2, participants who were PET scan 3 negative, or positive and age ≥60 years, received up to 4 additional cycles of AVD IV. Per protocol, collection and reporting of AEs was based on the individual study treatment received by the participant (i.e., AVD chemotherapy) at the time of the event. |
| OG002 | escBEACOPP Chemotherapy | In chemotherapy phase 2, participants who were PET scan 3 positive and age <60 years received up to four 3-week cycles of escBEACOPP IV. Per protocol, collection and reporting of AEs was based on the individual study treatment received by the participant (i.e., escBEACOPP chemotherapy) at the time of the event. |
|
|