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Pembrolizumab

Acalabrutinib

Tyrosine Kinase Inhibitors

Antineoplastic Agents, Immunological

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Tyrosine

A nonrandomized study that will be conducted in 2 stages. In the first stage, (Safety), subjects will receive Acalabrutinib Dose A orally administered (PO) twice daily (BID) in combination with Pembrolizumab Dose B administered every 3 weeks (Q3W).

The second stage was an expansion of Cohorts with the same dose regimen as the first stage. An additional expansion in subjects with Myelofibrosis was planned but not conducted.

AstraZeneca Clinical Study Information Center

This study is evaluating the safety, pharmacodynamics (PD), and efficacy of acalabrutinib and pembrolizumab in hematologic malignancies.

This is a Phase 1b/2, open-label, nonrandomized study that will be conducted in 2 stages. In the first stage, Part 1 of the study will determine the safety and preliminary efficacy of acalabrutinib and pembrolizumab in a limited group of B-cell malignancies. In the second stage, Part 2 allows for possible expansion cohorts into a wider range of B-cell malignancies, and Part 3 will evaluate the combination in subjects with myelofibrosis (MF).

ACP-196 (Acalabrutinib) in Combination With Pembrolizumab, for Treatment of Hematologic Malignancies

A Phase 1b/2 Proof-of-Concept Study of the Combination of ACP-196 (Acalabrutinib) and Pembrolizumab in Subjects With Hematologic Malignancies

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Treatment-emergent AEs were defined as those events that occurred on or after the first dose of study drug, through the treatment phase, and within 30 days following the last dose of study drug.

Severity of AEs was graded using the Common Terminology Criteria for Adverse Events (CTCAE), version 4.03

Number of participants with CTCAE Grade 5 (fatal) adverse events

Study drug-related AEs were those assessed by investigator as related to study treatment.

The severity of the AEs was assessed by NCI CTCAE Version 4.03 or higher. Drug-related AEs were those assessed by investigator as related to study treatment.

Grade 5 (fatal) AEs assessed by investigator as related to study treatment.

Serious AEs were those that resulted in death, were life-threatening, required or prolonged in-patient hospitalization, resulted in persistent or significant disability/incapacity, resulted in a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the investigational product, or were considered a significant medical event by the investigator based on medical judgment.

Serious AEs were those that resulted in death, were life-threatening, required or prolonged in-patient hospitalization, resulted in persistent or significant disability/incapacity, resulted in a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the investigational product, or were considered a significant medical event by the investigator based on medical judgment. The severity of the AEs was assessed by NCI CTCAE Version 4.03 or higher.

Grade 5 events were fatal events. Serious AEs were those that resulted in death, were life-threatening, required or prolonged in-patient hospitalization, resulted in persistent or significant disability/incapacity, resulted in a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the investigational product, or were considered a significant medical event by the investigator based on medical judgment.

Serious AEs were those that resulted in death, were life-threatening, required or prolonged in-patient hospitalization, resulted in persistent or significant disability/incapacity, resulted in a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the investigational product, or were considered a significant medical event by the investigator based on medical judgment. Drug-related AEs were those assessed by investigator as related to study treatment.

Serious AEs were those that resulted in death, were life-threatening, required or prolonged in-patient hospitalization, resulted in persistent or significant disability/incapacity, resulted in a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the investigational product, or were considered a significant medical event by the investigator based on medical judgment. The severity of the AEs was assessed by NCI CTCAE Version 4.03 or higher. Drug-related AEs were those assessed by investigator as related to study treatment.

Grade 5 AEs were fatal events. Serious AEs were those that resulted in death, were life-threatening, required or prolonged in-patient hospitalization, resulted in persistent or significant disability/incapacity, resulted in a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the investigational product, or were considered a significant medical event by the investigator based on medical judgment. Drug-related AEs were those assessed by investigator as related to study treatment.

AEs that discontinuation of study treatment, or a reduction in dosage, or a delay (temporary withholding) in treatment.

An adverse event that resulted in the permanent discontinuation of study treatment in the study.

An adverse event that caused a temporary withholding of study treatment.

An adverse event that resulted in a reduction in the dosage of study treatment for that participant.

The percentage of subjects who achieve a partial response or complete response

The interval from the first documentation of response to the earlier of the first documentation of definitive disease progression or death from any cause

The interval from the first dose date of acalabrutinib or pembrolizumab to the earlier of the first documentation of objective disease progression or death from any cause

The time from the first dose date of acalabrutinib or pembrolizumab until date of death due to any cause

The time from the first dose date of acalabrutinib or pembrolizumab to the start of the next treatment other than the study treatment

Merck Sharp & Dohme LLC

Acerta Pharma BV

All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.

All participants in this study received both study drugs and were therefore analysed together as a single treatment arm.

Participants receiving the different regimens were not analysed separately by regimen, as the study was designed to assess the safety of the combination study treatment.

The study included N=161 participants who received both acalabrutinib and pembrolizumab and are summarized together (from First stage safety lead-in and Second stage expansion). Stage 3 (additional expansion in subjects with Myelofibrosis) was planned but not conducted.

Acalabrutinib + Pembrolizumab

Age, Continuous

Sex: Female, Male

Hispanic or Latino

Not Hispanic or Latino

Not Reported

Race/Ethnicity, Customized

American Indian or Alaska Native

Asian

Black or African American

Native Hawaiian or Other Pacific Islander

White

Region of Enrollment

All participants in this study received both study drugs and were therefore analyzed together as a single treatment arm. Participants receiving the different regimens were not analyzed separately by regimen, as the study was designed to assess the safety of the combination study treatment.

Global Clinical Lead

Number of Participants With Treatment Emergent Adverse Events (AEs)

Number of Participants With Grade 3-4 Adverse Events

Number of Participants With Grade 5 Adverse Events

Number of Participants With Any Study-Drug Related AE

Number of Participants With Grade 3-4 Study-Drug Related AE

Number of Participants With Grade 5 Study-Drug Related AE

Number of Participants With Any SAE

Number of Participants With Grade 3-4 Any SAE

Number of Participants With Grade 5 Any SAE

Number of Participants With Any Study Drug-Related SAE

Number of Participants With Any Grade 3-4 Study Drug-Related SAE

Number of Participants With Any Grade 5 Study Drug-Related SAE

Number of Participants With AE Leading to Study Drug Discontinuation, Modification or Delay

Number of Participants With AE Leading to Study Drug Discontinuation

Number of Participants With AE Leading to Study Drug Delay

Number of Participants With AE Leading to Study Drug Modification

All participants in this study received both study drugs and were therefore analyzed together as a single treatment arm. Participants receiving the different regimens were not analyzed separately by regimen, as the study was designed to assess the the combination study treatment.

Overall Response Rate

Duration of Response

Progression-free Survival

Overall Survival

Time to Next Treatment

Overall Study

Antirheumatic Agents

Rituximab

Lenalidomide

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

Lenalidomide 20 mg once daily on days 1-21 of 28 days cycle for up to 6 courses and Rituximab 375 mg/m2 at day 14 of every course.

Lenalidomide 20 mg p.o. once daily, days 1-21 every 28 days, for 6 cycles

Rituximab 375 mg/m2 intravenously, day 14 of every course for 6 cycles

Stefano Sacchi, MD

The purpose of this study is to determine whether lenalidomide in association with rituximab is effective in the treatment of patients with indolent non follicular NHL relapsed after \>=2, but less than 4 prior lines of (immuno)chemotherapy.

Single arm, multicenter, open-label study divided in two phases: 1. Induction phase; 2. Follow-up phase. Enrolled patients will start the induction phase and receive the courses of R-Lenalidomide. At the end of the third cycle of R-Lenalidomide (week 12 of the study), the patients will be evaluated for tumor response (complete assessment); the patients with Progressive Disease (PD) will be withdrawn of the study. Two weeks after the end last courses of R-Lenalidomide (week 26 of the study) patients will be evaluated for tumor response (complete assessment). Patients with Complete Response (CR) and Partial Response (PR), and with a stable disease will undergo the follow up phase, while patients with PD will be withdrawn of the study.

Lenalidomide Plus Rituximab (R) in Non Follicular NHL

Phase II Study of Lenalidomide in Combination With Rituximab (R) for the Treatment of Indolent Non Follicular Non Hodgkin Lymphoma (NHL).

Evaluate the efficacy in term of Overall Response Rate (Complete Response + Partial Response) and Tumour Control Rate (Complete Response + Partial Response + Stable Disease)

The safety will be evaluated on the basis of recorded toxicities graded on a scale of 1 to 5 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
ACP-196 (Acalabrutinib) in Combination With Pembrolizumab, for Treatment of Hematologic Malignancies	NCT02362035	Follicular Lymp... CLL Small Lymphocyt... Richter's Syndr... Mantle Cell Lym... Indolent Non Ho... Waldenström Mac... Multiple Myelom... Hodgkin Lymphom... Burkitt Lymphom... Marginal Zone L... Mediastinal Lar... Hairy Cell Leuk...	Acalabrutinib Pembrolizumab	18 Years -	Acerta Pharma BV
ACP-196 (Acalabrutinib) in Combination With Pembrolizumab, for Treatment of Hematologic Malignancies	NCT02362035	Follicular Lymp... CLL Small Lymphocyt... Richter's Syndr... Mantle Cell Lym... Indolent Non Ho... Waldenström Mac... Multiple Myelom... Hodgkin Lymphom... Burkitt Lymphom... Marginal Zone L... Mediastinal Lar... Hairy Cell Leuk...	Acalabrutinib Pembrolizumab	18 Years -	Acerta Pharma BV
Lenalidomide Plus Rituximab (R) in Non Follicular NHL	NCT01830478	Indolent Non Ho...	Lenalidomide Rituximab	18 Years - 75 Years	Gruppo Italiano Studio Linfomi

Spots Global Cancer Trial Database for indolent non hodgkin lymphoma