A Phase 1/2 interventional study of Cobimetinib and Venetoclax in Multiple Myeloma, sponsored by Hoffmann-La Roche. Completed at 26 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-28.
Sponsored by Hoffmann-La Roche · Phase 1/2, Interventional, and Treatment
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Among 20 studies testing venetoclax in Multiple Myeloma — 4 open to participants now, 9 under way, 2 of them phase 3. venetoclax · Multiple Myeloma.
Among the 20 studies testing venetoclax in Multiple Myeloma, this one is the 9th largest by enrollment, is one of 2 that started in 2017, is one of 7 in phase 1/2, and was the 7th registered.
3,763 studies on the registry are indexed under Multiple Myeloma; 770 are open to participants now.
Browse Multiple Myeloma studies →4 of the 20 studies testing venetoclax in Multiple Myeloma are open now, in 3 countries. Recruiting first, the newest first:
Oncotherapeutics · Sites in United States
Universitätsklinikum Hamburg-Eppendorf · Sites in Germany
Ages 18+
University of Miami · Sites in United States
Ages 18+
Melbourne Health · Sites in Australia
Ages 18–75
By country, each count listing its studies:
venetoclax: first FDA approval 2016 (VENCLEXTA), first EMA approval 2016. What it is approved for, and how studies give it, is on its page →
Of the 585 Multiple Myeloma studies recruiting now, 430 (74%) set no upper age limit and 106 (18%) stop at 75 or younger; 36 take children under 18; 24 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
20 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 11 · Phase 2 13 · Phase 3 3
First in 2012; this study’s year is marked. 2 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 49 is above the median of 41 across 3,008 interventional studies indexed under Multiple Myeloma.
Median enrollment 42 across the 20 interventional studies. Of the 8 that completed or were terminated, 4 (50%) have results posted.
This tab as a report to print or save as PDF → With an account.
12 of 20 have an industry lead sponsor. The 10 most frequent:
Hoffmann-La Roche is the lead sponsor of 2,101 studies on the registry; 88 are open to participants now.
Of its 330 completed or terminated interventional studies of FDA-regulated products, 248 (75%) have results posted.
30 studies in Multiple Myeloma by Hoffmann-La Roche: 6 open now, 12 under way, 1 of them phase 3. Of 18 finished, 9 (50%) have results posted.
Among the 30 studies in Multiple Myeloma by Hoffmann-La Roche, this one is the 18th largest by enrollment of the 29 interventional ones that give a count, is one of 4 that started in 2017, is one of 5 in phase 1/2, and was the 13th registered.
Hoffmann-La Roche’s Multiple Myeloma studies by the year they started, since 2006.
4 of the studies testing venetoclax in Multiple Myeloma that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03844048Phase 3AbbVieAn Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial | 2027-08 |
| NCT05391750Emory UniversityVenetoclax and Tocilizumab for the Treatment of Patients With Relapsed or Refractory t(11;14) Multiple Myeloma | 2027-02-12 |
| NCT05853965Universitätsklinikum Hamburg-EppendorfCombination Treatment of Belantamab Mafodotin and Venetoclax in Treatment of Relapsed and Refractory t(11;14) Multiple Myeloma | 2027-04 |
| NCT02899052AbbVieStudy of Venetoclax in Combination With Carfilzomib and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma (MM) | 2027-06 |
Add all 4 to your calendar (.ics) → With an account.
Among the 20 studies testing venetoclax in Multiple Myeloma, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among Hoffmann-La Roche’s 30 in Multiple Myeloma:
This tab as a report to print or save as PDF → With an account.
This open-label, randomized, multicenter, triple-arm Phase Ib/II study is designed to assess the efficacy, safety, tolerability, and pharmacokinetics of cobimetinib administered as a single agent (Arm A), cobimetinib plus venetoclax (Arm B), and cobimetinib plus venetoclax plus atezolizumab (Arm C) in participants with relapsed and refractory multiple myeloma. Two successive cohorts will evaluate the safety of cobimetinib plus venetoclax and that of cobimetinib plus venetoclax plus atezolizumab in the selected population during the safety run-in phase of the study. Once the dose levels have demonstrated acceptable safety during this phase, randomization will begin for all treatment arms (Arms A, B, and C).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive the standard single-agent cobimetinib dose of 60 milligrams (mg) (3 tablets of 20 mg each) orally (PO) daily on Days 1-21 of each 28-day cycle until disease progression. Upon progression, participants will be allowed to receive treatment with cobimetinib and atezolizumab at the recommended Phase II dose of cobimetinib 60 mg PO on Days 1-21 plus atezolizumab intravenous (IV) infusion at a fixed dose of 840 mg on Day 1 and Day 15 of each 28-day cycle. Treatment will continue until the participant has disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurs first.
Drug: Cobimetinib · Drug: Atezolizumab
Participants will receive cobimetinib PO daily on Days 1-21 of each 28-day cycle plus venetoclax PO daily on Days 1-28 of each 28-day cycle, at the dose level identified in the safety run-in phase. Treatment will continue until the participant has disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurs first.
Drug: Cobimetinib · Drug: Venetoclax
Participants will receive cobimetinib PO daily on Days 1-21 of each 28-day cycle plus venetoclax PO daily on Days 1-28 of each 28-day cycle, at the dose level identified in the safety run-in phase plus atezolizumab IV infusion at a fixed dose of 840 mg on Day 1 and Day 15 of each 28-day cycle. Treatment will continue until the participant has disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurs first.
Drug: Cobimetinib · Drug: Venetoclax · Drug: Atezolizumab
Participants will receive cobimetinib (on Day 1-21) plus venetoclax (on Day 1-28) at escalated doses, in 28-day cycles, to identify the dose level with acceptable safety.
Drug: Cobimetinib · Drug: Venetoclax
Participants will receive cobimetinib (on Day 1-21) plus venetoclax (on Day 1-28) at escalated doses and atezolizumab (on Day 1 and Day 15) at a fixed dose of 840 mg IV, in 28-day cycles, to identify the dose level with acceptable safety.
Drug: Cobimetinib · Drug: Venetoclax · Drug: Atezolizumab
Cobimetinib will be administered as per the schedule specified in the respective arm.
Also known as: Cotellic®
Venetoclax will be administered as per the schedule specified in the respective arm.
Also known as: GDC-0199, ABT-199
Atezolizumab will be administered as per the schedule specified in the respective arm.
Percentage of Participants With Adverse Events (AEs)
An AE was any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with the treatment. An AE was therefore any unfavourable 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. New or pre-existing conditions which worsened during the study were also considered AEs.
Time frame: Randomization up to end of study (up to approximately 3 years, 7 months)
Percentage of Participants With Overall Response Rate (ORR) as Determined by the Investigator Using International Myeloma Working Group (IMWG) Response Criteria
ORR was defined as a stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) and was analyzed in the safety evaluable population and in the biomarker-selected sub-populations of t(11;14) and RAS mutations.
Time frame: From randomization to the first occurrence of a response as defined above (up to approximately 3 years, 7 months)
Percentage of Participants With Clinical Benefit as Determined by the Investigator Using IMWG Response Criteria
Clinical benefit rate (CBR) was defined as a minimal response (MR) or better (PR,VGPR, CR, sCR).
Time frame: From randomization to the first occurrence of disease progression or relapse or death from any cause, whichever occurs first (up to approximately 3 years, 7 months)
Progression-Free Survival (PFS) as Determined by the Investigator Using IMWG Response Criteria
PFS was defined as the time from randomization (for randomized participants) or first treatment date (for non-ranomized participants) to the first occurrence of disease progression or relapse as determined by the investigator using the IMWG criteria or death from any cause during the study, whichever occurred first.
Time frame: From enrollment or first treatment date to the first occurrence of disease progression or relapse or death from any cause, whichever occurs first (up to approximately 3 years, 7 months)
Duration of Response (DOR) as Determined by the Investigator Using IMWG Response Criteria
DOR was applicable to participants who achieved at least a PR, and was measured from the first observation of PR or better to the time of disease progression.
Time frame: Time from the first observation of partial response (PR) or better to the time of disease progression (up to approximately 3 years, 7 months)
Overall Survival (OS)
OS was defined as the time from randomization until death from any cause.
Time frame: From randomization until death from any cause (up to approximately 3 years, 7 months)
Area Under the Plasma Concentration Versus Time Curve (AUC) of Cobimetinib
AUC0-24hr area under the plasma concentration-time curve from time 0 to 24 hrs
Time frame: Pre-dose (within 1 hr), 2, 4, 6 hrs post-dose on Day 15 of Cycle 1 (cycle length: 28 days)
Maximum Observed Plasma Concentration (Cmax) of Cobimetinib
Cmax is the maximum observed plasma concentration at steady state.
Time frame: Pre-dose (within 1 hr), 2, 4, 6 hrs post-dose on Day 15 of Cycle 1 (cycle length: 28 days)
Time to Reach Cmax (Tmax) of Cobimetinib
Tmax is the time to reach Cmax.
Time frame: Pre-dose (within 1 hr), 2, 4, 6 hrs post-dose on Day 15 of Cycle 1 (cycle length: 28 days)
AUClast of Venetoclax
AUClast=area under the plasma concentration-time curve (samples collected to 8hr postdose on C1D15)
Time frame: Pre-dose (within 1 hr), 2, 4, 6, 8 hrs post-dose on Day 15 of Cycle 1 (cycle length: 28 days)
Cmax of Venetoclax
Cmax is the maximum observed plasma concentration at steady state.
Time frame: Pre-dose (within 1 hr), 2, 4, 6, 8 hrs post-dose on Day 15 of Cycle 1 (cycle length: 28 days)
Tmax of Venetoclax
Tmax is the time to reach Cmax.
Time frame: Pre-dose (within 1 hr), 2, 4, 6, 8 hrs post-dose on Day 15 of Cycle 1 (cycle length: 28 days)
Percentage of Participants With Anti-Drug Antibody (ADA) to Atezolizumab
Time frame: Pre-infusion (0 hr) on Day 1 of Cycles 1, 2, 3 (cycle length: 28 days); at treatment discontinuation visit (up to approximately 3 years, 7 months)
The study was conducted at 16 centers in 8 countries.
| Milestone | Safety Run-In: Cobimetinib + Venetoclax | Safety Run-In: Cobimetinib + Venetoclax + Atezolizumab | A: Cobimetinib | B: Cobimetinib + Venetoclax | C: Cobimetinib + Venetoclax + Atezolizumab |
|---|---|---|---|---|---|
| Started | 6 | 6 | 6 | 16 | 15 |
| Completed | 0 | 0 | 0 | 0 | 0 |
| Not completed | 6 | 6 | 6 | 16 | 15 |
| Withdrew: Death | 5 | 5 | 4 | 10 | 8 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 1 | 0 |
| Withdrew: Participant in another sponsor study. | 0 | 0 | 0 | 1 | 0 |
| Withdrew: Study terminated by sponsor | 1 | 0 | 2 | 3 | 7 |
| Withdrew: Withdrawal by subject | 0 | 1 | 0 | 0 | 0 |
| Withdrew: Participant summarized as 'ongoing' due to missing data entry for long-term follow up period on ecrf | 0 | 0 | 0 | 1 | 0 |
An AE was any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with the treatment. An AE was therefore any unfavourable 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. New or pre-existing conditions which worsened during the study were also considered AEs.
| Percentage of Participants | Safety Run-In: Cobimetinib + Venetoclax | Safety Run-In: Cobimetinib + Venetoclax + Atezolizumab | A: Cobimetinib | B: Cobimetinib + Venetoclax | C: Cobimetinib + Venetoclax + Atezolizumab |
|---|---|---|---|---|---|
| Percentage of Participants With Adverse Events (AEs) | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 |
ORR was defined as a stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) and was analyzed in the safety evaluable population and in the biomarker-selected sub-populations of t(11;14) and RAS mutations.
| Percentage of Participants | Safety Run-In: Cobimetinib + Venetoclax | Safety Run-In: Cobimetinib + Venetoclax + Atezolizumab | A: Cobimetinib | B: Cobimetinib + Venetoclax | C: Cobimetinib + Venetoclax + Atezolizumab |
|---|---|---|---|---|---|
| Safety Population | 16.7 (0.00 to 54.82) | 33.3 (0.00 to 79.39) | 0 (0.0 to 8.33) | 31.3 (5.41 to 57.09) | 26.7 (0.95 to 52.38) |
| t(11;14) Population | — | 100 (50.00 to 100.00) | 0 (0.00 to 50.00) | 100 (75.00 to 100.00) | 80.0 (34.94 to 100.00) |
| RAS Mutation Population | 0 (0.00 to 25.00) | 100 (50.00 to 100.00) | 0 (0.00 to 25.00) | 14.3 (0.00 to 47.35) | 37.5 (0.00 to 77.30) |
Clinical benefit rate (CBR) was defined as a minimal response (MR) or better (PR,VGPR, CR, sCR).
| Percentage of Participants | Safety Run-In: Cobimetinib + Venetoclax | Safety Run-In: Cobimetinib + Venetoclax + Atezolizumab | A: Cobimetinib | B: Cobimetinib + Venetoclax | C: Cobimetinib + Venetoclax + Atezolizumab |
|---|---|---|---|---|---|
| Percentage of Participants With Clinical Benefit as Determined by the Investigator Using IMWG Response Criteria | 33.3 (0.00 to 79.39) | 33.3 (0.00 to 79.39) | 0 (0.00 to 8.33) | 43.8 (16.32 to 71.18) | 33.3 (6.14 to 60.52) |
PFS was defined as the time from randomization (for randomized participants) or first treatment date (for non-ranomized participants) to the first occurrence of disease progression or relapse as determined by the investigator using the IMWG criteria or death from any cause during the study, whichever occurred first.
| Months | Safety Run-In: Cobimetinib + Venetoclax | Safety Run-In: Cobimetinib + Venetoclax + Atezolizumab | A: Cobimetinib | B: Cobimetinib + Venetoclax | C: Cobimetinib + Venetoclax + Atezolizumab |
|---|---|---|---|---|---|
| Progression-Free Survival (PFS) as Determined by the Investigator Using IMWG Response Criteria | 1.7 (0.9 to 3.7) | 3.4 (2.1 to 4.6) | 2.8 (1.9 to 4.7) | 4.9 (1.9 to 10.3) | 3.8 (1.4 to 4.7) |
DOR was applicable to participants who achieved at least a PR, and was measured from the first observation of PR or better to the time of disease progression.
| Months | Safety Run-In: Cobimetinib + Venetoclax | Safety Run-In: Cobimetinib + Venetoclax + Atezolizumab | B: Cobimetinib + Venetoclax | C: Cobimetinib + Venetoclax + Atezolizumab |
|---|---|---|---|---|
| Duration of Response (DOR) as Determined by the Investigator Using IMWG Response Criteria | 11.5 (NA to NA) | 4.9 (2.3 to NA) | 15.2 (1.9 to NA) | NA (1.9 to NA) |
OS was defined as the time from randomization until death from any cause.
| Months | Safety Run-In: Cobimetinib + Venetoclax | Safety Run-In: Cobimetinib + Venetoclax + Atezolizumab | A: Cobimetinib | B: Cobimetinib + Venetoclax | C: Cobimetinib + Venetoclax + Atezolizumab |
|---|---|---|---|---|---|
| Overall Survival (OS) | 11.4 (6.3 to 13.9) | 14.3 (14.1 to NA) | 12.9 (3.2 to NA) | 13.5 (8.0 to 26.9) | 22.0 (15.5 to NA) |
AUC0-24hr area under the plasma concentration-time curve from time 0 to 24 hrs
| hr*ng/mL | Safety Run-In: Cobimetinib + Venetoclax | Safety Run-In: Cobimetinib + Venetoclax + Atezolizumab | A: Cobimetinib | B: Cobimetinib + Venetoclax | C: Cobimetinib + Venetoclax + Atezolizumab |
|---|---|---|---|---|---|
| Area Under the Plasma Concentration Versus Time Curve (AUC) of Cobimetinib | 2390 ± 53.4 | 3190 ± 55.3 | — | 2540 ± 78.1 | 2900 ± 54.6 |
Cmax is the maximum observed plasma concentration at steady state.
| ng/mL | Safety Run-In: Cobimetinib + Venetoclax | Safety Run-In: Cobimetinib + Venetoclax + Atezolizumab | A: Cobimetinib | B: Cobimetinib + Venetoclax | C: Cobimetinib + Venetoclax + Atezolizumab |
|---|---|---|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of Cobimetinib | 157 ± 63.5 | 192 ± 61.7 | — | 148 ± 72.6 | 166 ± 61.0 |
Tmax is the time to reach Cmax.
| hr | Safety Run-In: Cobimetinib + Venetoclax | Safety Run-In: Cobimetinib + Venetoclax + Atezolizumab | A: Cobimetinib | B: Cobimetinib + Venetoclax | C: Cobimetinib + Venetoclax + Atezolizumab |
|---|---|---|---|---|---|
| Time to Reach Cmax (Tmax) of Cobimetinib | 4.00 (2.10 to 4.02) | 4.00 (2.05 to 5.73) | — | 4.00 (2.00 to 6.08) | 4.00 (2.23 to 6.37) |
AUClast=area under the plasma concentration-time curve (samples collected to 8hr postdose on C1D15)
| hr*ug/mL | Safety Run-In: Cobimetinib + Venetoclax | Safety Run-In: Cobimetinib + Venetoclax + Atezolizumab | B: Cobimetinib + Venetoclax | C: Cobimetinib + Venetoclax + Atezolizumab |
|---|---|---|---|---|
| AUClast of Venetoclax | 4.96 ± 67.2 | 5.13 ± 57.0 | 6.52 ± 63.7 | 6.52 ± 51.3 |
Cmax is the maximum observed plasma concentration at steady state.
| ug/mL | Safety Run-In: Cobimetinib + Venetoclax | Safety Run-In: Cobimetinib + Venetoclax + Atezolizumab | B: Cobimetinib + Venetoclax | C: Cobimetinib + Venetoclax + Atezolizumab |
|---|---|---|---|---|
| Cmax of Venetoclax | 1.25 ± 81.0 | 1.16 ± 48.7 | 1.32 ± 55.3 | 1.35 ± 18.2 |
Tmax is the time to reach Cmax.
| hr | Safety Run-In: Cobimetinib + Venetoclax | Safety Run-In: Cobimetinib + Venetoclax + Atezolizumab | B: Cobimetinib + Venetoclax | C: Cobimetinib + Venetoclax + Atezolizumab |
|---|---|---|---|---|
| Tmax of Venetoclax | 5.73 (3.92 to 5.77) | 5.65 (3.75 to 5.78) | 6.00 (3.95 to 8.50) | 5.92 (0 to 8.17) |
| Participants | Safety Run-In: Cobimetinib + Venetoclax + Atezolizumab | C: Cobimetinib + Venetoclax + Atezolizumab |
|---|---|---|
| Percentage of Participants With Anti-Drug Antibody (ADA) to Atezolizumab | 3 | 4 |
Collected over Randomization up to end of study (up to approximately 3 years, 7 months). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Safety Run-In: Cobimetinib + Venetoclax | 5/6 (83.3%) | 2/6 (33.3%) | 6/6 (100%) |
| Safety Run-In: Cobimetinib + Venetoclax + Atezolizumab | 5/6 (83.3%) | 3/6 (50%) | 6/6 (100%) |
| A: Cobimetinib | 4/6 (66.7%) | 3/6 (50%) | 5/6 (83.3%) |
| B: Cobimetinib + Venetoclax | 11/16 (68.8%) | 12/16 (75%) | 15/16 (93.8%) |
| C: Cobimetinib + Venetoclax + Atezolizumab | 8/15 (53.3%) | 11/15 (73.3%) | 15/15 (100%) |
| Event | Safety Run-In: Cobimetinib + Venetoclax | Safety Run-In: Cobimetinib + Venetoclax + Atezolizumab | A: Cobimetinib | B: Cobimetinib + Venetoclax | C: Cobimetinib + Venetoclax + Atezolizumab |
|---|---|---|---|---|---|
| ANAEMIABlood and lymphatic system disorders | 0/6 | 2/6 | 0/6 | 1/16 | 0/15 |
| PNEUMONIAInfections and infestations | 1/6 | 1/6 | 0/6 | 4/16 | 2/15 |
| FEBRILE NEUTROPENIABlood and lymphatic system disorders | 0/6 | 1/6 | 0/6 | 0/16 | 1/15 |
| NEUTROPENIABlood and lymphatic system disorders | 0/6 | 1/6 | 0/6 | 1/16 | 2/15 |
| THROMBOCYTOPENIABlood and lymphatic system disorders | 0/6 | 1/6 | 0/6 | 2/16 | 1/15 |
| HAEMOPHILUS SEPSISInfections and infestations | 0/6 | 0/6 | 1/6 | 0/16 | 0/15 |
| INFECTIONInfections and infestations | 1/6 | 1/6 | 0/6 | 0/16 | 0/15 |
| PNEUMONIA PNEUMOCOCCALInfections and infestations | 0/6 | 0/6 | 1/6 | 0/16 | 0/15 |
| STAPHYLOCOCCAL SEPSISInfections and infestations | 0/6 | 0/6 | 1/6 | 0/16 | 0/15 |
| URINARY TRACT INFECTIONInfections and infestations | 1/6 | 0/6 | 0/6 | 0/16 | 0/15 |
| Event | Safety Run-In: Cobimetinib + Venetoclax | Safety Run-In: Cobimetinib + Venetoclax + Atezolizumab | A: Cobimetinib | B: Cobimetinib + Venetoclax | C: Cobimetinib + Venetoclax + Atezolizumab |
|---|---|---|---|---|---|
| DIARRHOEAGastrointestinal disorders | 5/6 | 6/6 | 2/6 | 13/16 | 13/15 |
| NAUSEAGastrointestinal disorders | 6/6 | 4/6 | 1/6 | 5/16 | 10/15 |
| NEUTROPENIABlood and lymphatic system disorders | 3/6 | 4/6 | 0/6 | 2/16 | 7/15 |
| FATIGUEGeneral disorders | 4/6 | 1/6 | 0/6 | 3/16 | 3/15 |
| ANAEMIABlood and lymphatic system disorders | 1/6 | 2/6 | 1/6 | 9/16 | 9/15 |
| BLOOD CREATINE PHOSPHOKINASE INCREASEDInvestigations | 3/6 | 3/6 | 1/6 | 4/16 | 2/15 |
| RASHSkin and subcutaneous tissue disorders | 2/6 | 2/6 | 3/6 | 1/16 | 5/15 |
| VOMITINGGastrointestinal disorders | 1/6 | 0/6 | 0/6 | 6/16 | 3/15 |
| LEUKOPENIABlood and lymphatic system disorders | 2/6 | 0/6 | 0/6 | 0/16 | 3/15 |
| THROMBOCYTOPENIABlood and lymphatic system disorders | 1/6 | 2/6 | 0/6 | 3/16 | 5/15 |
| Age, Continuous(Years) | Safety Run-In: Cobimetinib + Venetoclax | Safety Run-In: Cobimetinib + Venetoclax + Atezolizumab | A: Cobimetinib | B: Cobimetinib + Venetoclax | C: Cobimetinib + Venetoclax + Atezolizumab | Total |
|---|---|---|---|---|---|---|
| Mean | 65.8 ± 7.6 | 66.5 ± 6.1 | 68.0 ± 5.9 | 64.1 ± 6.0 | 61.5 ± 10.5 | 64.3 ± 7.9 |
| Sex: Female, Male(Participants) | Safety Run-In: Cobimetinib + Venetoclax | Safety Run-In: Cobimetinib + Venetoclax + Atezolizumab | A: Cobimetinib | B: Cobimetinib + Venetoclax | C: Cobimetinib + Venetoclax + Atezolizumab | Total |
|---|---|---|---|---|---|---|
| Female | 4 | 3 | 2 | 6 | 3 | 18 |
| Male | 2 | 3 | 4 | 10 | 12 | 31 |
| Race/Ethnicity, Customized(Participants) | Safety Run-In: Cobimetinib + Venetoclax | Safety Run-In: Cobimetinib + Venetoclax + Atezolizumab | A: Cobimetinib | B: Cobimetinib + Venetoclax | C: Cobimetinib + Venetoclax + Atezolizumab | Total |
|---|---|---|---|---|---|---|
| White | 6 | 6 | 6 | 16 | 15 | 49 |
| Race/Ethnicity, Customized(Participants) | Safety Run-In: Cobimetinib + Venetoclax | Safety Run-In: Cobimetinib + Venetoclax + Atezolizumab | A: Cobimetinib | B: Cobimetinib + Venetoclax | C: Cobimetinib + Venetoclax + Atezolizumab | Total |
|---|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 1 | 1 | 2 |
| Not Hispanic or Latino | 6 | 6 | 6 | 14 | 11 | 43 |
| Not Stated | 0 | 0 | 0 | 1 | 2 | 3 |
| Unknown | 0 | 0 | 0 | 0 | 1 | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Nov 2017 to primary completion in May 2021, 42 months.
Results were first posted in Feb 2023, 1 year 9 months after primary completion.
Of 98 industry-sponsored phase 1/2 interventional studies under Multiple Myeloma, half reached primary completion within 64 months of starting (the median), counting those still running; a quarter within 42 and three quarters within 90. This study's 42 months is below that.
Counting every sponsor, half of 201 studies reached it within 65 months; a quarter within 44 and three quarters within 92.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Cobimetinib · Venetoclax · Atezolizumab