Solid Tumor
Conditions
Brief summary
The main purpose of this study is to evaluate the safety of the colony-stimulating factor 1 receptor (CSF-1R) inhibitor LY3022855 in combination with durvalumab or tremelimumab in participants with advanced solid tumors.
Interventions
Sponsors
AstraZeneca
Eli Lilly and Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must have histological or cytological evidence of a diagnosis of cancer that is not amenable to curative therapy. * Part B: Must have a type of malignancy that is being studied. * Part A and Part B (ovarian cancer cohort only): Must be willing to undergo pretreatment and on-treatment core needle or excisional tumor biopsies. * Part A (all cohorts): Have the presence of measureable and /or nonmeasurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. * Part B (all cohorts): Have the presence of measurable disease as defined by the RECIST 1.1. * Have adequate normal organ and marrow function, including the following: * Absolute neutrophil count ≥ 1.5 x 10⁹/Liters (L) (1500/cubic millimeters) * Platelet count ≥ 100 x 10⁹/L (≥100,000/cubic millimeters) * Hemoglobin ≥9 grams per deciliter or ≥5.6 millimoles per liter * Serum Creatinine ≤1.5 × institutional upper limit of normal (ULN) * Total bilirubin ≤1.5 × institutional ULN * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × institutional ULN OR ≤5 × institutional ULN for participants with liver metastases * International normalized ratio (INR) or prothrombin time (PT) INR ≤1.5 × institutional ULN or PT ≤5 seconds above institutional ULN * PTT or activated partial thromboplastin time (aPTT) ≤5 seconds above institutional ULN * Thyroid stimulating hormone (TSH) OR free thyroxine (T4) within the normal limits * Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale.
Exclusion criteria
* Are currently receiving or have had prior use of immunosuppressive medication within 28 days before the first dose of study drug, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 milligrams/day of prednisone, or an equivalent corticosteroid. * Have symptomatic central nervous system (CNS) malignancy or metastasis. * Have had any prior Grade ≥3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, have any unresolved irAE Grade \>1, or any irAE that led to the permanent discontinuation of prior immunotherapy. * Have experienced a Grade ≥3 AE or a neurologic or ocular AE of any grade while receiving prior immunotherapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recommended Phase 2 Dose of LY3022855 Combined With Durvalumab (Maximum Tolerated Dose [MTD]) | Cycle 1 (4 weeks) | Recommended Phase 2 dose of LY3022855 that could be safely administered in combination with Durvalumab was based on defined dose limiting toxicities (DLT) assessment and MTD definition. MTD is defined as the highest tested dose that has less than 33% probability of causing a DLT. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Exhibit Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)] | Baseline through Measured Progressive Disease or Death (Up To 24 months) | ORR was estimated as the percentage of participants with best response of Complete Response (CR) or Partial Response (PR), based on RECIST version 1.1 divided by the total number of participants. CR is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. Progressive disease (PD) is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. |
| Percentage of Participants Who Exhibit Stable Disease (SD) or CR or PR [Disease Control Rate (DCR)] | Baseline through Measured Progressive Disease (Up To 24 months) | DCR is the percentage of participants with a best overall response of CR, PR or SD as defined by RECIST v1.1. CR is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. |
| Number of Participants With Anti-LY3022855, Anti-Durvalumab or Anti-Tremelimumab Antibodies | Baseline through Follow-up (Up To 24 Months) | Number of participants with positive Anti-LY3022855, Anti-Durvalumab or Anti-Tremelimumab Antibodies was summarized by cohorts. |
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3022855 in Combination With Either Durvalumab or Tremelimumab, and the Single-Dose | Cycle 1 Day 1: 2 hours post End of Infusion (EOI), Day 2: 24-hour post EOI, Day 3: 48 hour post EOI; Cycle 2 Day 8: 2 h post-EOI, Day 9: 24 h post-EOI, Day 10: 48 h post-EOI | Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3022855 in Combination with either Durvalumab or Tremelimumab, and the Single-Dose |
Countries
Belgium, Czechia, Israel, United States
Participant flow
Pre-assignment details
This study has two parts: Part A: Dose-escalation of LY3022855 combined with durvalumab or tremelimumab. Part B: Dose-expansion of LY3022855 combined with durvalumab.
Participants by arm
| Arm | Count |
|---|---|
| Cohort D1A: LY3022855 (25 mg,QW)+Durvalumab (750mg,Q2W) 25 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV. Treatment may continue until disease progression or discontinuation. | 4 |
| Cohort D2A: LY3022855 (50 mg,QW)+Durvalumab (750mg,Q2W) 50 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV. Treatment may continue until disease progression or discontinuation. | 3 |
| Cohort D3A: LY3022855 (75 mg,QW)+Durvalumab (750mg,Q2W) 75 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV. Treatment may continue until disease progression or discontinuation. | 3 |
| Cohort D4A: LY3022855 (100 mg,QW)+Durvalumab (750mg,Q2W) 100 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV. Treatment may continue until disease progression or discontinuation. | 5 |
| Cohort T1A: LY3022855 (50 mg,QW) +Tremelimumab (75mg,Q4W) 50 mg LY3022855 administered QW intravenously (IV) in combination with 75 mg tremelimumab administered Q4W IV. Treatment may continue until disease progression or discontinuation. | 3 |
| Cohort T2A: LY3022855 (100 mg,QW) +Tremelimumab (75mg,Q4W) 100 mg LY3022855 administered QW intravenously (IV) in combination with 75 mg tremelimumab administered Q4W IV. Treatment may continue until disease progression or discontinuation. | 5 |
| Cohort T3A: LY3022855 (100 mg,QW) +Tremelimumab (225 mg,Q4W) 100 mg LY3022855 administered QW intravenously (IV) in combination with 225 mg tremelimumab administered Q4W IV. Treatment may continue until disease progression or discontinuation. | 5 |
| Cohort T4A: LY3022855 (100 mg,QW) +Tremelimumab (750 mg,Q4W) 100 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg tremelimumab administered Q4W IV. Treatment may continue until disease progression or discontinuation. | 5 |
| Cohort B-1: NSCLC LY3022855+ Durvalumab Cohort B-1: NSCLC
100 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV. Treatment may continue until disease progression or discontinuation. | 19 |
| Cohort B-1: OVARIAN LY3022855+ Durvalumab Cohort B-1: OVARIAN
100 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV. Treatment may continue until disease progression or discontinuation. | 20 |
| Total | 72 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 |
| Overall Study | Death | 2 | 3 | 1 | 0 | 1 | 3 | 1 | 1 | 4 | 3 |
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Physician Decision | 2 | 0 | 1 | 1 | 0 | 0 | 0 | 1 | 2 | 1 |
| Overall Study | Reason Not Collected | 0 | 0 | 1 | 0 | 0 | 0 | 2 | 1 | 4 | 9 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 4 |
Baseline characteristics
| Characteristic | Cohort D2A: LY3022855 (50 mg,QW)+Durvalumab (750mg,Q2W) | Cohort D3A: LY3022855 (75 mg,QW)+Durvalumab (750mg,Q2W) | Cohort D4A: LY3022855 (100 mg,QW)+Durvalumab (750mg,Q2W) | Cohort T1A: LY3022855 (50 mg,QW) +Tremelimumab (75mg,Q4W) | Cohort T2A: LY3022855 (100 mg,QW) +Tremelimumab (75mg,Q4W) | Cohort D1A: LY3022855 (25 mg,QW)+Durvalumab (750mg,Q2W) | Cohort T3A: LY3022855 (100 mg,QW) +Tremelimumab (225 mg,Q4W) | Cohort T4A: LY3022855 (100 mg,QW) +Tremelimumab (750 mg,Q4W) | Cohort B-1: NSCLC LY3022855+ Durvalumab | Cohort B-1: OVARIAN LY3022855+ Durvalumab | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 68.7 years STANDARD_DEVIATION 13.4 | 59.0 years STANDARD_DEVIATION 10.8 | 56.8 years STANDARD_DEVIATION 6.4 | 59.3 years STANDARD_DEVIATION 7.1 | 55.2 years STANDARD_DEVIATION 20.1 | 65.8 years STANDARD_DEVIATION 5.7 | 62.4 years STANDARD_DEVIATION 11.7 | 60.6 years STANDARD_DEVIATION 9.6 | 62.5 years STANDARD_DEVIATION 8.5 | 55.8 years STANDARD_DEVIATION 15 | 59.7 years STANDARD_DEVIATION 11.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 3 Participants | 4 Participants | 3 Participants | 4 Participants | 4 Participants | 3 Participants | 4 Participants | 19 Participants | 19 Participants | 66 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) White | 2 Participants | 3 Participants | 4 Participants | 3 Participants | 5 Participants | 4 Participants | 3 Participants | 3 Participants | 19 Participants | 20 Participants | 66 Participants |
| Region of Enrollment Belgium | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 8 Participants | 11 Participants | 19 Participants |
| Region of Enrollment Czechia | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Region of Enrollment Israel | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 3 Participants | 0 Participants | 2 Participants | 1 Participants | 5 Participants | 5 Participants | 19 Participants |
| Region of Enrollment United States | 3 Participants | 3 Participants | 4 Participants | 1 Participants | 2 Participants | 4 Participants | 3 Participants | 4 Participants | 5 Participants | 4 Participants | 33 Participants |
| Sex: Female, Male Female | 1 Participants | 3 Participants | 3 Participants | 2 Participants | 2 Participants | 1 Participants | 3 Participants | 2 Participants | 8 Participants | 20 Participants | 45 Participants |
| Sex: Female, Male Male | 2 Participants | 0 Participants | 2 Participants | 1 Participants | 3 Participants | 3 Participants | 2 Participants | 3 Participants | 11 Participants | 0 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 4 | 3 / 3 | 1 / 3 | 0 / 5 | 1 / 3 | 3 / 5 | 1 / 5 | 1 / 5 | 4 / 19 | 3 / 20 |
| other Total, other adverse events | 4 / 4 | 3 / 3 | 3 / 3 | 5 / 5 | 3 / 3 | 5 / 5 | 5 / 5 | 5 / 5 | 19 / 19 | 20 / 20 |
| serious Total, serious adverse events | 0 / 4 | 0 / 3 | 0 / 3 | 1 / 5 | 0 / 3 | 2 / 5 | 3 / 5 | 3 / 5 | 12 / 19 | 5 / 20 |
Outcome results
Primary
Recommended Phase 2 Dose of LY3022855 Combined With Durvalumab (Maximum Tolerated Dose [MTD])
Recommended Phase 2 dose of LY3022855 that could be safely administered in combination with Durvalumab was based on defined dose limiting toxicities (DLT) assessment and MTD definition. MTD is defined as the highest tested dose that has less than 33% probability of causing a DLT.
Time frame: Cycle 1 (4 weeks)
Population: All participants who received at least one dose of study drug LY3022855 + Durvalumab.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LY3022855 + Durvalumab | Recommended Phase 2 Dose of LY3022855 Combined With Durvalumab (Maximum Tolerated Dose [MTD]) | 100 milligrams (mg) |
Secondary
Number of Participants With Anti-LY3022855, Anti-Durvalumab or Anti-Tremelimumab Antibodies
Number of participants with positive Anti-LY3022855, Anti-Durvalumab or Anti-Tremelimumab Antibodies was summarized by cohorts.
Time frame: Baseline through Follow-up (Up To 24 Months)
Population: All participants who received at least one dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| LY3022855 + Durvalumab | Number of Participants With Anti-LY3022855, Anti-Durvalumab or Anti-Tremelimumab Antibodies | 0 Participants |
| Cohort D2A: LY3022855 (50 mg,QW)+Durvalumab (750mg,Q2W) | Number of Participants With Anti-LY3022855, Anti-Durvalumab or Anti-Tremelimumab Antibodies | 0 Participants |
| Cohort D3A: LY3022855 (75 mg,QW)+Durvalumab (750mg,Q2W) | Number of Participants With Anti-LY3022855, Anti-Durvalumab or Anti-Tremelimumab Antibodies | 1 Participants |
| Cohort D4A: LY3022855 (100 mg,QW)+Durvalumab (750mg,Q2W) | Number of Participants With Anti-LY3022855, Anti-Durvalumab or Anti-Tremelimumab Antibodies | 1 Participants |
| Cohort T1A: LY3022855 (50 mg,QW) +Tremelimumab (75mg,Q4W) | Number of Participants With Anti-LY3022855, Anti-Durvalumab or Anti-Tremelimumab Antibodies | 1 Participants |
| Cohort T2A: LY3022855 (100 mg,QW) +Tremelimumab (75mg,Q4W) | Number of Participants With Anti-LY3022855, Anti-Durvalumab or Anti-Tremelimumab Antibodies | 2 Participants |
| Cohort T3A: LY3022855 (100 mg,QW) +Tremelimumab (225 mg,Q4W) | Number of Participants With Anti-LY3022855, Anti-Durvalumab or Anti-Tremelimumab Antibodies | 3 Participants |
| Cohort T4A: LY3022855 (100 mg,QW) +Tremelimumab (750 mg,Q4W) | Number of Participants With Anti-LY3022855, Anti-Durvalumab or Anti-Tremelimumab Antibodies | 2 Participants |
| Cohort B-1: NSCLC LY3022855+ Durvalumab | Number of Participants With Anti-LY3022855, Anti-Durvalumab or Anti-Tremelimumab Antibodies | 1 Participants |
| Cohort B-1: OVARIAN LY3022855+ Durvalumab | Number of Participants With Anti-LY3022855, Anti-Durvalumab or Anti-Tremelimumab Antibodies | 7 Participants |
Secondary
Percentage of Participants Who Exhibit Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)]
ORR was estimated as the percentage of participants with best response of Complete Response (CR) or Partial Response (PR), based on RECIST version 1.1 divided by the total number of participants. CR is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. Progressive disease (PD) is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.
Time frame: Baseline through Measured Progressive Disease or Death (Up To 24 months)
Population: All participants who received at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LY3022855 + Durvalumab | Percentage of Participants Who Exhibit Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)] | 0.0 Percentage of participants |
| Cohort D2A: LY3022855 (50 mg,QW)+Durvalumab (750mg,Q2W) | Percentage of Participants Who Exhibit Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)] | 0.0 Percentage of participants |
| Cohort D3A: LY3022855 (75 mg,QW)+Durvalumab (750mg,Q2W) | Percentage of Participants Who Exhibit Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)] | 0.0 Percentage of participants |
| Cohort D4A: LY3022855 (100 mg,QW)+Durvalumab (750mg,Q2W) | Percentage of Participants Who Exhibit Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)] | 40.0 Percentage of participants |
| Cohort T1A: LY3022855 (50 mg,QW) +Tremelimumab (75mg,Q4W) | Percentage of Participants Who Exhibit Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)] | 0.0 Percentage of participants |
| Cohort T2A: LY3022855 (100 mg,QW) +Tremelimumab (75mg,Q4W) | Percentage of Participants Who Exhibit Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)] | 0.0 Percentage of participants |
| Cohort T3A: LY3022855 (100 mg,QW) +Tremelimumab (225 mg,Q4W) | Percentage of Participants Who Exhibit Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)] | 0.0 Percentage of participants |
| Cohort T4A: LY3022855 (100 mg,QW) +Tremelimumab (750 mg,Q4W) | Percentage of Participants Who Exhibit Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)] | 0.0 Percentage of participants |
| Cohort B-1: NSCLC LY3022855+ Durvalumab | Percentage of Participants Who Exhibit Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)] | 0.0 Percentage of participants |
| Cohort B-1: OVARIAN LY3022855+ Durvalumab | Percentage of Participants Who Exhibit Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)] | 5.0 Percentage of participants |
Secondary
Percentage of Participants Who Exhibit Stable Disease (SD) or CR or PR [Disease Control Rate (DCR)]
DCR is the percentage of participants with a best overall response of CR, PR or SD as defined by RECIST v1.1. CR is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.
Time frame: Baseline through Measured Progressive Disease (Up To 24 months)
Population: All participants who received at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LY3022855 + Durvalumab | Percentage of Participants Who Exhibit Stable Disease (SD) or CR or PR [Disease Control Rate (DCR)] | 75.0 Percentage of participants |
| Cohort D2A: LY3022855 (50 mg,QW)+Durvalumab (750mg,Q2W) | Percentage of Participants Who Exhibit Stable Disease (SD) or CR or PR [Disease Control Rate (DCR)] | 33.3 Percentage of participants |
| Cohort D3A: LY3022855 (75 mg,QW)+Durvalumab (750mg,Q2W) | Percentage of Participants Who Exhibit Stable Disease (SD) or CR or PR [Disease Control Rate (DCR)] | 66.7 Percentage of participants |
| Cohort D4A: LY3022855 (100 mg,QW)+Durvalumab (750mg,Q2W) | Percentage of Participants Who Exhibit Stable Disease (SD) or CR or PR [Disease Control Rate (DCR)] | 80.0 Percentage of participants |
| Cohort T1A: LY3022855 (50 mg,QW) +Tremelimumab (75mg,Q4W) | Percentage of Participants Who Exhibit Stable Disease (SD) or CR or PR [Disease Control Rate (DCR)] | 33.3 Percentage of participants |
| Cohort T2A: LY3022855 (100 mg,QW) +Tremelimumab (75mg,Q4W) | Percentage of Participants Who Exhibit Stable Disease (SD) or CR or PR [Disease Control Rate (DCR)] | 20.0 Percentage of participants |
| Cohort T3A: LY3022855 (100 mg,QW) +Tremelimumab (225 mg,Q4W) | Percentage of Participants Who Exhibit Stable Disease (SD) or CR or PR [Disease Control Rate (DCR)] | 20.0 Percentage of participants |
| Cohort T4A: LY3022855 (100 mg,QW) +Tremelimumab (750 mg,Q4W) | Percentage of Participants Who Exhibit Stable Disease (SD) or CR or PR [Disease Control Rate (DCR)] | 40.0 Percentage of participants |
| Cohort B-1: NSCLC LY3022855+ Durvalumab | Percentage of Participants Who Exhibit Stable Disease (SD) or CR or PR [Disease Control Rate (DCR)] | 21.1 Percentage of participants |
| Cohort B-1: OVARIAN LY3022855+ Durvalumab | Percentage of Participants Who Exhibit Stable Disease (SD) or CR or PR [Disease Control Rate (DCR)] | 25.0 Percentage of participants |
Secondary
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3022855 in Combination With Either Durvalumab or Tremelimumab, and the Single-Dose
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3022855 in Combination with either Durvalumab or Tremelimumab, and the Single-Dose
Time frame: Cycle 1 Day 1: 2 hours post End of Infusion (EOI), Day 2: 24-hour post EOI, Day 3: 48 hour post EOI; Cycle 2 Day 8: 2 h post-EOI, Day 9: 24 h post-EOI, Day 10: 48 h post-EOI
Population: All participants who received at least one dose of study drug and had evaluable PK data. Cohort B-1 NSCLC and Cohort B-1 OVARIAN data were combined because they are escalating cohort and the participants are received the same dose.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| LY3022855 + Durvalumab | Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3022855 in Combination With Either Durvalumab or Tremelimumab, and the Single-Dose | Cycle 1 | 5.33 micrograms per milliliter (ug/mL) | Geometric Coefficient of Variation 46 |
| LY3022855 + Durvalumab | Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3022855 in Combination With Either Durvalumab or Tremelimumab, and the Single-Dose | Cycle 2: | 5.11 micrograms per milliliter (ug/mL) | Geometric Coefficient of Variation 61 |
| Cohort D2A: LY3022855 (50 mg,QW)+Durvalumab (750mg,Q2W) | Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3022855 in Combination With Either Durvalumab or Tremelimumab, and the Single-Dose | Cycle 2: | 16.6 micrograms per milliliter (ug/mL) | Geometric Coefficient of Variation 8 |
| Cohort D2A: LY3022855 (50 mg,QW)+Durvalumab (750mg,Q2W) | Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3022855 in Combination With Either Durvalumab or Tremelimumab, and the Single-Dose | Cycle 1 | 11.9 micrograms per milliliter (ug/mL) | Geometric Coefficient of Variation 72 |
| Cohort D3A: LY3022855 (75 mg,QW)+Durvalumab (750mg,Q2W) | Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3022855 in Combination With Either Durvalumab or Tremelimumab, and the Single-Dose | Cycle 1 | 23.8 micrograms per milliliter (ug/mL) | Geometric Coefficient of Variation 22 |
| Cohort D3A: LY3022855 (75 mg,QW)+Durvalumab (750mg,Q2W) | Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3022855 in Combination With Either Durvalumab or Tremelimumab, and the Single-Dose | Cycle 2: | 35.3 micrograms per milliliter (ug/mL) | Geometric Coefficient of Variation 17 |
| Cohort D4A: LY3022855 (100 mg,QW)+Durvalumab (750mg,Q2W) | Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3022855 in Combination With Either Durvalumab or Tremelimumab, and the Single-Dose | Cycle 2: | 43.1 micrograms per milliliter (ug/mL) | Geometric Coefficient of Variation 38 |
| Cohort D4A: LY3022855 (100 mg,QW)+Durvalumab (750mg,Q2W) | Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3022855 in Combination With Either Durvalumab or Tremelimumab, and the Single-Dose | Cycle 1 | 32.9 micrograms per milliliter (ug/mL) | Geometric Coefficient of Variation 28 |
| Cohort T1A: LY3022855 (50 mg,QW) +Tremelimumab (75mg,Q4W) | Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3022855 in Combination With Either Durvalumab or Tremelimumab, and the Single-Dose | Cycle 1 | 13.8 micrograms per milliliter (ug/mL) | Geometric Coefficient of Variation 30 |
| Cohort T1A: LY3022855 (50 mg,QW) +Tremelimumab (75mg,Q4W) | Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3022855 in Combination With Either Durvalumab or Tremelimumab, and the Single-Dose | Cycle 2: | 15.1 micrograms per milliliter (ug/mL) | Geometric Coefficient of Variation 33 |
| Cohort T2A: LY3022855 (100 mg,QW) +Tremelimumab (75mg,Q4W) | Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3022855 in Combination With Either Durvalumab or Tremelimumab, and the Single-Dose | Cycle 2: | 44.4 micrograms per milliliter (ug/mL) | Geometric Coefficient of Variation 39 |
| Cohort T2A: LY3022855 (100 mg,QW) +Tremelimumab (75mg,Q4W) | Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3022855 in Combination With Either Durvalumab or Tremelimumab, and the Single-Dose | Cycle 1 | 32 micrograms per milliliter (ug/mL) | Geometric Coefficient of Variation 30 |
| Cohort T3A: LY3022855 (100 mg,QW) +Tremelimumab (225 mg,Q4W) | Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3022855 in Combination With Either Durvalumab or Tremelimumab, and the Single-Dose | Cycle 1 | 30.3 micrograms per milliliter (ug/mL) | Geometric Coefficient of Variation 25 |
| Cohort T4A: LY3022855 (100 mg,QW) +Tremelimumab (750 mg,Q4W) | Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3022855 in Combination With Either Durvalumab or Tremelimumab, and the Single-Dose | Cycle 2: | 30.7 micrograms per milliliter (ug/mL) | Geometric Coefficient of Variation 16 |
| Cohort T4A: LY3022855 (100 mg,QW) +Tremelimumab (750 mg,Q4W) | Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3022855 in Combination With Either Durvalumab or Tremelimumab, and the Single-Dose | Cycle 1 | 27 micrograms per milliliter (ug/mL) | Geometric Coefficient of Variation 34 |