. 2020 Mar 25;20(2):55–73. doi: 10.1007/s40268-020-00301-8

Table 4.

Clinical trials exploring talazoparib combined with immunotherapy and chemotherapy in solid tumors (www.clinicaltrials.gov)

Reference	Phase	Patients (n)	Description	Population	Outcome	Trial, status
NCT03330405 [106]	Ib/II	242	Talazoparib + avelumab	1. Locally advanced (primary or recurrent) or metastatic solid tumors (NSCLC, TNBC, hormone receptor-positive BC, platinum-sensitive EOC, UC, and CRPC) 2. BRCA or ATM gene defect	1. DLT 2. ORR 3. PFS 4. OS 5. Pharmacokinetics 6. Antidrug antibody levels of avelumab 7. Biomarkers (PSA, Ca-125, PD-L1 expression level)	NCT03330405 Recruiting
NCT02358200 [119]	I	23	Talazoparib days (1–21) + carboplatin weekly, 750 μg/day + paclitaxel weekly, 0.75* MTD μg/day	1. Solid tumors 2. TNBC 3. gBRCAm	1. ORR 2. Safety and tolerability	NCT02358200 Active, not recruiting
NCT02049593 [120]	I	41	Dose-escalation study. Patients are assigned to either Arm 1: temozolomide on days (1–5) + talazoparib 0.5–1 mg daily Arm 2: irinotecan on days 1, 15 + talazoparib 0.5–1 mg daily One cycle equaled 28 days	1. Unresectable, locally advanced or metastatic solid tumor 2. Any BRCA status	1. MTD 2. Pharmacokinetics 3. Biomarkers for the effect of talazoparib in combination with temozolomide or irinotecan 4. PFS 5. OS 6. Adverse events	NCT02049593 Active, not recruiting

Reference

Phase

Patients (n)

Description

Population

Outcome

Trial, status

NCT03330405 [106]

Ib/II

242

Talazoparib + avelumab

1. Locally advanced (primary or recurrent) or metastatic solid tumors (NSCLC, TNBC, hormone receptor-positive BC, platinum-sensitive EOC, UC, and CRPC)

2. BRCA or ATM gene defect

1. DLT

2. ORR

3. PFS

4. OS

5. Pharmacokinetics

6. Antidrug antibody levels of avelumab

7. Biomarkers (PSA, Ca-125, PD-L1 expression level)

NCT03330405 Recruiting

NCT02358200 [119]

Talazoparib days (1–21) + carboplatin weekly, 750 μg/day + paclitaxel weekly, 0.75* MTD μg/day

1. Solid tumors

2. TNBC

3. gBRCAm

1. ORR

2. Safety and tolerability

NCT02358200 Active, not recruiting

NCT02049593 [120]

Dose-escalation study. Patients are assigned to either

Arm 1: temozolomide on days (1–5) + talazoparib 0.5–1 mg daily

Arm 2: irinotecan on days 1, 15 + talazoparib 0.5–1 mg daily

One cycle equaled 28 days

1. Unresectable, locally advanced or metastatic solid tumor

2. Any BRCA status

1. MTD

2. Pharmacokinetics

3. Biomarkers for the effect of talazoparib in combination with temozolomide or irinotecan

4. PFS

5. OS

6. Adverse events

NCT02049593 Active, not recruiting

ATM ataxia-telangiectasia mutated gene, BC breast cancer, BRCA breast cancer susceptibility genes, CRPC castration-resistant prostate cancer, DLT dose-limiting toxicity, EOC epithelial ovarian cancer, MTD maximum tolerated dose, NSCLC non-small cell lung cancer, ORR objective response rate, OS overall survival, PD-L1 programmed death-ligand 1, PFS progression-free survival, PSA prostate-specific antigen, TNBC triple-negative breast cancer, UC urothelial cancer