Researchers are looking for new ways to treat people with solid tumors, lymphomas (blood cancers), and a certain type of skin cancer. The goals of this study are to learn:
* About the safety of pembrolizumab (the study medicine) and if people tolerate it * What happens to different doses of pembrolizumab in a person's body over time * How the cancer responds (gets smaller or goes away) to treatment
For participants with relapsed or refractory classical Hodgkin lymphoma (cHL) or primary mediastinal large B-cell lymphoma (PMBCL)
Has a confirmed diagnosis of relapsed or refractory cHL or PMBCL after the most recent therapy
Has radiographically measurable disease per Lugano classification
Has surgically completely resected and histologically/pathologically confirmed diagnosis of Stage IIB, IIC, III or IV cutaneous melanoma
Has known additional malignancy that is progressing or has required active treatment
Has known active (central nervous system) CNS metastases and/or carcinomatous meningitis
Has active autoimmune disease that has required systemic treatment in past 2 years
Has history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
Parallel
Pembrolizumab
Biological/Vaccine25 mg/mL solution for intravenous infusion.
Arm 1: Number of Participants Who Experience an Adverse Event (AE)
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a study intervention. The number of participants with solid tumors or lymphomas who experience an AE will be reported.
Arm 1: Number of Participants Who Discontinue Study Treatment Due To an AE
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a study intervention. The number of participants with solid tumors or lymphomas who discontinue study treatment due to an AE will be reported.
Arm 1: Area Under the Concentration-Time Curve (AUC) of Pembrolizumab
AUC is defined as the area under the concentration-time curve of pembrolizumab. Blood samples will be collected at specified intervals for the determination of AUC. AUC in participants with solid tumors or lymphomas will be reported.
Arm 1: Maximum Concentration (Cmax) of Pembrolizumab
Cmax is defined as the maximum concentration of pembrolizumab reached. Blood samples will be collected at pre-specified intervals for the determination of Cmax. Cmax in participants with solid tumors or lymphomas will be reported.
Arm 1: ORR per RECIST 1.1 by Investigator Assessment
ORR is defined as complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 by investigator assessment. ORR in participants with solid tumors will be reported.
Arm 1: ORR per Lugano Classification by Investigator Assessment
ORR is defined as complete response (CR: all target lymph nodes must have regressed to normal size defined as ≤1.5 cm in longest diameter) or partial response (PR: ≥50% decrease in sum of products of diameters of target lesions from baseline, and no individual lesion meets the criteria for progression), per Lugano classification (Cheson et al, Journal of Clinical Oncology, 2014). ORR in participants with lymphomas as assessed by investigator will be reported.
Arm 1: Duration of Response (DOR) per RECIST 1.1 by Investigator Assessment
For participants who demonstrate a complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR per RECIST 1.1 by investigator assessment in participants with solid tumors will be reported.
Arm 1: DOR per Lugano Classification by Investigator Assessment
For participants who demonstrate confirmed CR or PR, DOR is defined as the time from the first documented evidence of CR (all target lymph nodes must have regressed to normal size defined as ≤1.5 cm in longest diameter) or PR (≥50% decrease in sum of products of diameters of target lesions from baseline, and no individual lesion meets the criteria for progression) per Lugano classification (Cheson et al, Journal of Clinical Oncology, 2014) until progressive disease (PD: based on the progression of any single lesion and other certain requirements) or death due to any cause, whichever occurs first. DOR in participants with lymphomas as assessed by investigator will be reported.
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