Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, Follicular

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphosarcoma

Follicular Lymphoma

Antineoplastic Agents

All Drugs and Chemicals

Atezolizumab

Obinutuzumab

Lenalidomide

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

Immune Checkpoint Inhibitors

Antineoplastic Agents, Immunological

Participants were administered obinutuzumab, Atezolizumab, and 15 mg of Lenalidomide.

Participants were administered obinutuzumab, Atezolizumab, and 20 mg of Lenalidomide.

Atezolizumab will be administered at a flat dose of 840 mg on Days 1 and 15 of Cycles 2 to 6, given in 28-day cycles as induction treatment and 840 mg on Days 1 and 2 of each month, given as maintenance treatment.

Atezolizumab (MPDL3280A) [TECENTRIQ]

Lenalidomide will be administered orally once daily on Days 1 to 21 of Cycles 1 to 6 (28-day cycles) during induction treatment and on Days 1 to 21 of each month during maintenance treatment. Lenalidomide will be administered at a dose of 15 or 20 mg (dose may be de-escalated to 10 mg) during induction treatment and at 10 mg during maintenance treatment. During the expansion phase, lenalidomide will be administered at the RP2D during induction treatment and at 10 mg during maintenance treatment.

Obinutuzumab will be administered by intravenous infusion at an absolute (flat) dose of 1000 mg on Days 1, 8, and 15 of the first cycle and on Day 1 of each subsequent cycle during induction treatment, and on Day 1 of every other month (i.e., every 2 months) during maintenance treatment.

Clinical Trials

This study will evaluate the safety, efficacy, pharmacokinetics and immunogenicity of induction treatment consisting of atezolizumab in combination with obinutuzumab plus lenalidomide in patients with relapsed or refractory follicular lymphoma (FL), followed by maintenance treatment with atezolizumab plus obinutzumab plus lenalidomide in patients who achieve a complete response (CR), a partial response (PR), or stable disease at end of induction.

A Study Evaluating the Safety and Efficacy of Atezolizumab in Combination With Obinutuzumab Plus Lenalidomide in Patients With Relapsed or Refractory Follicular Lymphoma

A Phase Ib/II Study Evaluating the Safety and Efficacy of Atezolizumab in Combination With Obinutuzumab Plus Lenalidomide in Patients With Relapsed or Refractory Follicular Lymphoma

Complete response (CR) was evaluated through use of PET-CT scans, using the Modified Lugano 2014 criteria. Response was determined by the IRC.

CR was evaluated through use of PET-CT scans, using the Modified Lugano 2014 criteria. Response was determined by the Investigator.

CR was evaluated through use of CT scans, using the Lugano 2014 criteria. Response was determined by the IRC and by the Investigator.

Objective response was evaluated through use of PET-CT scans, using the Lugano 2014 or modified Lugano 2014 criteria. Response was determined by the IRC and by the Investigator.

Objective response was evaluated through use of CT scans alone, using the Lugano 2014. Response was determined by the IRC and by the Investigator.

Best Response was evaluated through use of CT scans alone, using the Lugano 2014. Response was determined by the Investigator.

An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.

Does limiting toxicity (DLT) is defined as any one of the following events occurring during Cycle 2 of treatment and assessed by the investigator as related to study treatment: - Adverse event of any grade that leads to a delay of more than 14 days at the start of the next treatment cycle; - Hematologic adverse events (neutropenia, thrombocytopenia); - Non-hematologic adverse event, except IRRs, diarrhea, nausea or vomiting

The following abbreviations apply in the table: Ind C = Induction Cycle; D = Day; Maint M = Maintenance Month; TRTC = Study Drug Completion or Early Discontinuation; PK FU = Pharmacokinetics and Immunogenicity Follow-up; YR = Year

The following abbreviations apply in the table: Ind C = Induction Cycle; D = Day; HR = Hour

The following abbreviations apply in the table: Ind C = Induction Cycle; D = Day; Maint M = Maintenance Month; TRTC = Study Drug Completion or Early Discontinuation; PK FU = Pharmacokinetics and Immunogenicity Follow-up; YR = Year. All baseline and post-baseline samples from participants were negative for HAHAs to obinutuzumab and the results are shown below.

The following abbreviations apply in the table: Ind C = Induction Cycle; D = Day; Maint M = Maintenance Month; TRTC = Study Drug Completion or Early Discontinuation; PK FU = Pharmacokinetics and Immunogenicity Follow-up; YR = Year. All baseline and post-baseline samples were negative for ATAs to atezolizumab and the results are shown below.

Hoffmann-La Roche

The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.

Participants were administered obinutuzumab, atezolizumab, and 15 mg of lenalidomide

Atezolizumab-G-lena 15mg

Participants were administered obinutuzumab, atezolizumab, and 20 mg of lenalidomide.

Atezolizumab-G-lena 20mg

Total

Age, Continuous

Sex: Female, Male

Race/Ethnicity, Customized

Enrollment for this study was stopped early as the Sponsor chose not to claim superiority over existing therapies.

Medical Communications

Participants were administered obinutuzumab, atezolizumab, and 15 mg of lenalidomide.

As no DLTs were observed, the dose of 20 mg lenalidomide was confirmed as the recommended Phase II dose (RP2D) for lenalidomide. Only participants who received lenalidomide induction at the 20 mg RP2D were included in the Efficacy Evaluable population, hence participants in the Atezo-G-L 15 mg arm were not included in the efficacy analysis.

Percentage of Participants Achieving Complete Response (CR) at End of Induction (EOI), as Determined by the Independent Review Committee (IRC) Using Modified Lugano 2014 Criteria

Percentage of Participants Achieving CR at EOI, as Determined by the Investigator Using Modified Lugano 2014 Criteria

Determined by the IRC with CT or MRI

Determined by Investigator with CT or MRI

Percentage of Participants Achieving CR at EOI, as Determined by the IRC and Investigator Using Lugano 2014 Criteria

Determined by IRC, based on Lugano 2014 - PET

Determined by Inv., based on Lugano 2014 - PET

Determined by IRC, Modified Lugano 2014 - PET-CT

Determined by Inv, Modified Lugano 2014 - PET-CT

Percentage of Participants With Objective Response (CR or PR) at EOI as Determined by the IRC and Investigator on the Basis of PET-CT Scans

Determined by IRC, based on Lugano 2014 - CT

Determined by Inv., based on Lugano 2014 - CT

Percentage of Participants With Objective Response (CR or PR) at EOI as Determined by the IRC and Investigator on the Basis of CT Scans Alone

Best Response (CR,PR)

Percentage of Participants With Best Response (CR or PR) During the Study as Determined by the Investigator on the Basis of CT Scans Alone

Adverse Events

Serious Adverse Events

The Safety Evaluable Population included participants who received at least one dose of any study treatment.

Percentage of Participants With Adverse Events and Serious Adverse Events

Number of Participants With Dose-limiting Toxicities (DLTs) During Cycle 2 of Study Treatment

Ind C1 D1 - Predose

Ind C1 D1 - 30 min. Postdose

Ind C2 D1 - Predose

Ind C2 D1 - 30 min. Postdose

Ind C4 D1 - Predose

Ind C4 D1 - 30 min. Postdose

Ind C6 D1 - Predose

Ind C6 D1 - 30 min. Postdose

Maint M1 - Predose

Maint M7 - Predose

Maint M13 - Predose

Maint M19 - Predose

TRTC

OD120FU

O1YFU

Serum Concentration of Obinutuzumab (mcg/mL)

Ind C2 D15 - Predose

Maint M1 - Day 2, 30 min. Postdose

Maint M4 - Predose

PK FU 120D

PK FU 1YR

Serum Concentration of Atezolizumab (mcg/mL)

Ind C1 D15 - Predose

Ind C1 D15 - 2.0 hr. Postdose

Ind C2 D15 - 30 min. Postdose

Ind C2 D15 -1.0 hr. Postdose

Ind C2 D15 - 2.0 hr. Postdose

Ind C2 D15 - 4.0 hr. Postdose

Ind C2 D15 - 8.0 hr. Postdose

Ind C6 D15 - Predose

Ind C6 D15 - 2.0 hr. Postdose

Serum Concentration of Lenalidomide (ng/mL)

Baseline - Negative

Ind C6 D1 - Negative

Study drug completion or early discontinuation - Negative

OB, PK, IMMUNO FU 120D - Negative

OB, PK, IMMUNO FU 1YR - Negative

Number of Participants Positive for Human Anti-human Antibodies (HAHA) to Obinutuzumab

Ind C2 D1 - Negative

Ind C2 D15 - Negative

Ind C4 D1 - Negative

Maint M1 - Negative

Maint M4 - Negative

Maint M7 - Negative

Maint M13 - Negative

Maint M19 - Negative

ATEZO, PK, IMMUNO FU 120D - Negative

ATEZO, PK, IMMUNO FU 1YR - Negative

Number of Participants Positive for Anti-therapeutic Antibodies (ATAs) to Atezolizumab

Overall Study

Spots Global Cancer Trial Database for A Study Evaluating the Safety and Efficacy of Atezolizumab in Combination With Obinutuzumab Plus Lenalidomide in Patients With Relapsed or Refractory Follicular Lymphoma

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial