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A Study of LY3022855 in Combination With Durvalumab or Tremelimumab in Participants With Advanced Solid Tumors
Phase 1 trial testing LY3022855 in Solid Tumor in 72 participants. Completed in 14 December 2018.
| Lead sponsor | Eli Lilly and Company |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 72 |
| Start date | 16 June 2016 |
| Primary completion | 14 December 2018 |
| Estimated completion | 14 December 2018 |
| Sites | 14 locations across Belgium, United States, Israel, Czechia |
Eli Lilly and Company — full company profile →
18 and older, any sex, with Solid Tumor. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| LY3022855 + Durvalumab | 100 |
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 dia
| Group | Value | 95% CI |
|---|---|---|
| Cohort D1A: LY3022855 (25 mg,QW)+Durvalumab (750mg,Q2W) | 0.0 | 0.0 – 0.0 |
| Cohort D2A: LY3022855 (50 mg,QW)+Durvalumab (750mg,Q2W) | 0.0 | 0.0 – 0.0 |
| Cohort D3A: LY3022855 (75 mg,QW)+Durvalumab (750mg,Q2W) | 0.0 | 0.0 – 0.0 |
| Cohort D4A: LY3022855 (100 mg,QW)+Durvalumab (750mg,Q2W) | 40.0 | 7.6 – 81.1 |
| Cohort T1A: LY3022855 (50 mg,QW) +Tremelimumab (75mg,Q4W) | 0.0 | 0.0 – 0.0 |
| Cohort T2A: LY3022855 (100 mg,QW) +Tremelimumab (75mg,Q4W) | 0.0 | 0.0 – 0.0 |
| Cohort T3A: LY3022855 (100 mg,QW) +Tremelimumab (225 mg,Q4W) | 0.0 | 0.0 – 0.0 |
| Cohort T4A: LY3022855 (100 mg,QW) +Tremelimumab (750 mg,Q4W) | 0.0 | 0.0 – 0.0 |
| Cohort B-1: NSCLC LY3022855+ Durvalumab | 0.0 | 0.0 – 0.0 |
| Cohort B-1: OVARIAN LY3022855+ Durvalumab | 5.0 | 0.3 – 21.6 |
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 lesi
| Group | Value | 95% CI |
|---|---|---|
| Cohort D1A: LY3022855 (25 mg,QW)+Durvalumab (750mg,Q2W) | 75.0 | 24.9 – 98.7 |
| Cohort D2A: LY3022855 (50 mg,QW)+Durvalumab (750mg,Q2W) | 33.3 | 1.7 – 86.5 |
| Cohort D3A: LY3022855 (75 mg,QW)+Durvalumab (750mg,Q2W) | 66.7 | 13.5 – 98.3 |
| Cohort D4A: LY3022855 (100 mg,QW)+Durvalumab (750mg,Q2W) | 80.0 | 34.3 – 99.0 |
| Cohort T1A: LY3022855 (50 mg,QW) +Tremelimumab (75mg,Q4W) | 33.3 | 1.7 – 86.5 |
| Cohort T2A: LY3022855 (100 mg,QW) +Tremelimumab (75mg,Q4W) | 20.0 | 1.0 – 65.7 |
| Cohort T3A: LY3022855 (100 mg,QW) +Tremelimumab (225 mg,Q4W) | 20.0 | 1.0 – 65.7 |
| Cohort T4A: LY3022855 (100 mg,QW) +Tremelimumab (750 mg,Q4W) | 40.0 | 7.6 – 81.1 |
| Cohort B-1: NSCLC LY3022855+ Durvalumab | 21.1 | 7.5 – 41.9 |
| Cohort B-1: OVARIAN LY3022855+ Durvalumab | 25.0 | 10.4 – 45.6 |
Number of participants with positive Anti-LY3022855, Anti-Durvalumab or Anti-Tremelimumab Antibodies was summarized by cohorts.
| Group | Value | 95% CI |
|---|---|---|
| Cohort D1A: LY3022855 (25 mg,QW)+Durvalumab (750mg,Q2W) | 0 | |
| Cohort D2A: LY3022855 (50 mg,QW)+Durvalumab (750mg,Q2W) | 0 | |
| Cohort D3A: LY3022855 (75 mg,QW)+Durvalumab (750mg,Q2W) | 1 | |
| Cohort D4A: LY3022855 (100 mg,QW)+Durvalumab (750mg,Q2W) | 1 | |
| Cohort T1A: LY3022855 (50 mg,QW) +Tremelimumab (75mg,Q4W) | 1 | |
| Cohort T2A: LY3022855 (100 mg,QW) +Tremelimumab (75mg,Q4W) | 2 | |
| Cohort T3A: LY3022855 (100 mg,QW) +Tremelimumab (225 mg,Q4W) | 3 | |
| Cohort T4A: LY3022855 (100 mg,QW) +Tremelimumab (750 mg,Q4W) | 2 | |
| Cohort B-1: NSCLC LY3022855+ Durvalumab | 1 | |
| Cohort B-1: OVARIAN LY3022855+ Durvalumab | 7 |
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3022855 in Combination with either Durvalumab or Tremelimumab, and the Single-Dose
| Group | Value | 95% CI |
|---|---|---|
| Cohort D1A: LY3022855 (25 mg,QW)+Durvalumab (750mg,Q2W) | 5.33 | ± 46 |
| Cohort D2A: LY3022855 (50 mg,QW)+Durvalumab (750mg,Q2W) | 11.9 | ± 72 |
| Cohort D3A: LY3022855 (75 mg,QW)+Durvalumab (750mg,Q2W) | 23.8 | ± 22 |
| All LY3022855 (100 mg,QW)+Durvalumab (750mg,Q2W) | 32.9 | ± 28 |
| Cohort T1A: LY3022855 (50 mg,QW) +Tremelimumab (75mg,Q4W) | 13.8 | ± 30 |
| Cohort T2A: LY3022855 (100 mg,QW) +Tremelimumab (75mg,Q4W) | 32 | ± 30 |
| Cohort T3A: LY3022855 (100 mg,QW) +Tremelimumab (225 mg,Q4W) | 30.3 | ± 25 |
| Cohort T4A: LY3022855 (100 mg,QW) +Tremelimumab (750 mg,Q4W) | 27 | ± 34 |
| Group | Value | 95% CI |
|---|---|---|
| Cohort D1A: LY3022855 (25 mg,QW)+Durvalumab (750mg,Q2W) | 5.11 | ± 61 |
| Cohort D2A: LY3022855 (50 mg,QW)+Durvalumab (750mg,Q2W) | 16.6 | ± 8 |
| Cohort D3A: LY3022855 (75 mg,QW)+Durvalumab (750mg,Q2W) | 35.3 | ± 17 |
| All LY3022855 (100 mg,QW)+Durvalumab (750mg,Q2W) | 43.1 | ± 38 |
| Cohort T1A: LY3022855 (50 mg,QW) +Tremelimumab (75mg,Q4W) | 15.1 | ± 33 |
| Cohort T2A: LY3022855 (100 mg,QW) +Tremelimumab (75mg,Q4W) | 44.4 | ± 39 |
| Cohort T4A: LY3022855 (100 mg,QW) +Tremelimumab (750 mg,Q4W) | 30.7 | ± 16 |
Time frame: Up To 30 Months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Cohort D1A: LY3022855 (25 … | Cohort D2A: LY3022855 (50 … | Cohort D3A: LY3022855 (75 … | Cohort D4A: LY3022855 (100… | Cohort T1A: LY3022855 (50 … | Cohort T2A: LY3022855 (100… | Cohort T3A: LY3022855 (100… | Cohort T4A: LY3022855 (100… | Cohort B-1: NSCLC LY302285… | Cohort B-1: OVARIAN LY3022… |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Confusional state | Psychiatric disorders | — | — | — | — | — | — | — | — | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — | — | — | — | — | — | — | — | — |
| Febrile neutropenia | Blood and lymphatic system disorders | — | — | — | — | — | — | — | — | — | — |
| Pericardial effusion | Cardiac disorders | — | — | — | — | — | — | — | — | — | — |
| Right ventricular dysfunction | Cardiac disorders | — | — | — | — | — | — | — | — | — | — |
| Stress cardiomyopathy | Cardiac disorders | — | — | — | — | — | — | — | — | — | — |
| Hypothyroidism | Endocrine disorders | — | — | — | — | — | — | — | — | — | — |
| Abdominal discomfort | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — | — |
| Autoimmune colitis | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — | — |
| Duodenal obstruction | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — | — |
| Dysphagia | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — | — |
| Intestinal obstruction | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — | — |
| Stomatitis | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — | — |
| Generalised oedema | General disorders | — | — | — | — | — | — | — | — | — | — |
| Pyrexia | General disorders | — | — | — | — | — | — | — | — | — | — |
| Hepatic haemorrhage | Hepatobiliary disorders | — | — | — | — | — | — | — | — | — | — |
| Hypersensitivity | Immune system disorders | — | — | — | — | — | — | — | — | — | — |
| Atypical pneumonia | Infections and infestations | — | — | — | — | — | — | — | — | — | — |
| Clostridium difficile infection | Infections and infestations | — | — | — | — | — | — | — | — | — | — |
| Diverticulitis | Infections and infestations | — | — | — | — | — | — | — | — | — | — |
| Peritonitis bacterial | Infections and infestations | — | — | — | — | — | — | — | — | — | — |
| Respiratory tract infection | Infections and infestations | — | — | — | — | — | — | — | — | — | — |
| Reaction | System | Cohort D1A: LY3022855 (25 … | Cohort D2A: LY3022855 (50 … | Cohort D3A: LY3022855 (75 … | Cohort D4A: LY3022855 (100… | Cohort T1A: LY3022855 (50 … | Cohort T2A: LY3022855 (100… | Cohort T3A: LY3022855 (100… | Cohort T4A: LY3022855 (100… | Cohort B-1: NSCLC LY302285… | Cohort B-1: OVARIAN LY3022… |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Fatigue | General disorders | — | — | — | — | — | — | — | — | — | — |
| Aspartate aminotransferase increased | Investigations | — | — | — | — | — | — | — | — | — | — |
| Decreased appetite | Metabolism and nutrition disorders | — | — | — | — | — | — | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — | — |
| Blood creatine phosphokinase increased | Investigations | — | — | — | — | — | — | — | — | — | — |
| Alanine aminotransferase increased | Investigations | — | — | — | — | — | — | — | — | — | — |
| Hypertension | Vascular disorders | — | — | — | — | — | — | — | — | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — | — | — | — | — | — | — | — | — |
| Periorbital oedema | Eye disorders | — | — | — | — | — | — | — | — | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — | — |
| Face oedema | General disorders | — | — | — | — | — | — | — | — | — | — |
| Oedema peripheral | General disorders | — | — | — | — | — | — | — | — | — | — |
| Headache | Nervous system disorders | — | — | — | — | — | — | — | — | — | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — | — | — | — | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — | — |
| Dry mouth | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — | — |
| Pyrexia | General disorders | — | — | — | — | — | — | — | — | — | — |
| Amylase increased | Investigations | — | — | — | — | — | — | — | — | — | — |
| Blood alkaline phosphatase increased | Investigations | — | — | — | — | — | — | — | — | — | — |
| Hyponatraemia | Metabolism and nutrition disorders | — | — | — | — | — | — | — | — | — | — |
| Myalgia | Musculoskeletal and connective tissue disorders | — | — | — | — | — | — | — | — | — | — |
| Hypothyroidism | Endocrine disorders | — | — | — | — | — | — | — | — | — | — |
| Lacrimation increased | Eye disorders | — | — | — | — | — | — | — | — | — | — |
| Abdominal distension | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — | — |
| Ascites | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — | — |
| Constipation | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — | — |
| Chills | General disorders | — | — | — | — | — | — | — | — | — | — |
| Influenza like illness | General disorders | — | — | — | — | — | — | — | — | — | — |
| Lipase increased | Investigations | — | — | — | — | — | — | — | — | — | — |
| Lymphocyte count decreased | Investigations | — | — | — | — | — | — | — | — | — | — |
| Weight decreased | Investigations | — | — | — | — | — | — | — | — | — | — |
| Hypoalbuminaemia | Metabolism and nutrition disorders | — | — | — | — | — | — | — | — | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — | — | — | — | — | — | — | — | — |
| Muscle spasms | Musculoskeletal and connective tissue disorders | — | — | — | — | — | — | — | — | — | — |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — | — | — | — | — | — | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — | — | — | — | — | — |
| Pruritus | Skin and subcutaneous tissue disorders | — | — | — | — | — | — | — | — | — | — |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | — | — | — | — | — | — | — | — | — | — |
| Abdominal pain upper | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — | — |
Most-reported serious reactions: Confusional state, Anaemia, Febrile neutropenia, Pericardial effusion, Right ventricular dysfunction, Stress cardiomyopathy, Hypothyroidism, Abdominal discomfort.
Data from ClinicalTrials.gov NCT02718911 adverse events section.
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.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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