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Carcinoma

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Neoplasms by Histologic Type

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Respiratory Tract Diseases

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Liver Diseases

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Nivolumab

Mitogens

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

50 milligrams (mg) Galunisertib administered orally once daily (QD) on Day 1 through Day 14 of each 4-week cycle in combination with 3 milligrams per kilogram (3 mg/kg) nivolumab given intravenously (IV), every 2 weeks (Q2W), (Day 1 and Day 15). Participants may continue to receive study drug until discontinuation criteria are met.

50 mg Galunisertib administered orally twice daily (BID) on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV, Q2W,(Day 1 and Day 15). Participants may continue to receive study drug until discontinuation criteria are met.

80 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV, Q2W, (Day 1 and Day 15). Participants may continue to receive study drug until discontinuation criteria are met.

150 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV, Q2W,(Day 1 and Day 15). Participants may continue to receive study drug until discontinuation criteria are met.

150 mg Galunisertib administered orally BID for the first 14 days of each 4-week cycle in combination with 3 mg/kg nivolumab given IV, Q2W, (Day 1 and Day 15) of each 4-week cycle. Participants may continue to receive study drug until discontinuation criteria are met.

Galunisertib

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

The main purpose of this study is to evaluate the safety, tolerability, and efficacy of the study drug known as galunisertib in combination with nivolumab in participants with advanced refractory solid tumors and in recurrent or refractory non-small cell lung cancer (NSCLC) or hepatocellular carcinoma (HCC).

A Study of Galunisertib (LY2157299) in Combination With Nivolumab in Advanced Refractory Solid Tumors and in Recurrent or Refractory NSCLC, or Hepatocellular Carcinoma

A Phase 1b/2 Dose Escalation and Cohort Expansion Study of the Safety, Tolerability and Efficacy of a Novel Transforming Growth Factor-beta Receptor I Kinase Inhibitor (Galunisertib) Administered in Combination With Anti-PD-1 (Nivolumab) in Advanced Refractory Solid Tumors (Phase 1b) and in Recurrent or Refractory Non-small Cell Lung Cancer or Hepatocellular Carcinoma (Phase 2)

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

The MTD is defined as the highest tested dose that has less than 33% probability of causing a dose limiting toxicity (DLT).

Minimum Concentration (Cmin) of Nivolumab

Area under the plasma concentration curve from time zero to 24 hours of galunisertib for Cycle 1 and Cycle 2.

Participants with treatment-emergent anti-nivolumab antibodies when administered with galunisertib were participants with a 4-fold or greater increase in titer from baseline measurement (treatment-boosted). If baseline result is ADA not present, then the subject is TE ADA+, if there is at least 1 postbaseline result of ADA present with titer ≥ 40 (treatment-induced).

PFS was defined as the time from the date of first study treatment to the first evidence of disease progression as defined by response evaluation criteria in solid tumors (RECIST) v1.1 or death from any cause. Progressive Disease (PD) was 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. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of randomization, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date.

Objective Response Rate was the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. PD was 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. Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with at least 1 measurable lesion, multiplied by 100.

Duration of response was measured from the date of documented response to the date of first progression of disease or the date of death due to any cause, whichever is earlier.

Time to response was measured from the date of first study treatment to the first documented response of Complete Response (CR) or Partial Response (PR).

Overall Survival was determined from the date of first study treatment until death due to any cause.

Bristol-Myers Squibb

Eli Lilly and Company

All participants who received at least one dose of study drug.

50 mg Galunisertib administered orally QD on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV every Q2W on Day 1 and Day 15 for 2 cycles. Participants may continue to receive study drug until discontinuation criteria are met.

Galunisertib + Nivolumab (Cohort 1) Phase 1b

50 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles. Participants may continue to receive study drug until discontinuation criteria are met.

Galunisertib + Nivolumab (Cohort 2) Phase 1b

80 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles. Participants may continue to receive study drug until discontinuation criteria are met.

Galunisertib + Nivolumab (Cohort 3) Phase 1b

150 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles. Participants may continue to receive study drug until discontinuation criteria are met.

Galunisertib + Nivolumab (Cohort 4) Phase 1b

150 mg Galunisertib administered orally BID for the first 14 days of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W (Day 1 and Day 15) of each 4-week cycle. Participants may continue to receive study drug until discontinuation criteria are met.

Galunisertib + Nivolumab (NSCLC) Phase 2

Galunisertib + Nivolumab (HCC) Phase 2

50 mg Galunisertib administered orally daily on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given intravenously (IV) every 2 weeks (Day 1 and Day 15) for 2 cycles. Participants may continue to receive study drug until discontinuation criteria are met.

50 mg Galunisertib administered orally twice daily on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV every 2 weeks (Day 1 and Day 15) for 2 cycles. Participants may continue to receive study drug until discontinuation criteria are met.

80 mg Galunisertib administered orally twice daily on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV every 2 weeks(Day 1 and Day 15) for 2 cycles. Participants may continue to receive study drug until discontinuation criteria are met.

150 mg Galunisertib administered orally twice daily on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV every 2 weeks (Day 1 and Day 15) for 2 cycles. Participants may continue to receive study drug until discontinuation criteria are met.

150 mg Galunisertib given orally twice daily for the first 14 days of each 4 week cycle in combination with 3 mg/kg nivolumab given IV every 2 weeks (Day 1 and Day 15) of each 4-week cycle. Participants may continue to receive study drug until discontinuation criteria are met.

Galunisertib + Nivolumab - Non Small Cell Lung Cancer (NSCLC) Phase 2

Galunisertib + Nivolumab - Hepatocellular Carcinoma(HCC) Phase 2

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Spain

Region of Enrollment

Due low enrollment, the HCC cohort was terminated early.

Chief Medical Officer

Cohort 1: 50 mg Galunisertib administered QD on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV, every Q2W, on Day 1 and Day 15 for 2 cycles.

Cohort 2: 50 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles.

Cohort 3: 80 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles.

Cohort 4: 150 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles.

Phase 1b Participants

All participants who received at least one dose of study drug in Phase 1b per protocol.

Phase 1b: Maximum Tolerated Dose (MTD) of Galunisertib in Combination With Nivolumab

50 mg Galunisertib administered orally QD on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV every Q2W on Day 1 and Day 15 for 2 cycles.

50 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles.

80 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles.

150 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles.

Galunisertib + Nivolumab ( HCC) Phase 2

All participants who received at least one dose of study drug and had evaluable PK data.

Pharmacokinetics (PK): Minimum Concentration (Cmin) of Nivolumab

50 mg Galunisertib administered orally QD on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W (Day 1 and Day 15) for 2 cycles. Participants may continue to receive study drug until discontinuation criteria are met.

50 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W (Day 1 and Day 15) for 2 cycles. Participants may continue to receive study drug until discontinuation criteria are met.

80 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W (Day 1 and Day 15) for 2 cycles. Participants may continue to receive study drug until discontinuation criteria are met.

150 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W (Day 1 and Day 15) for 2 cycles. Participants may continue to receive study drug until discontinuation criteria are met.

Galunisertib + Nivolumab (NSCLC ) Phase 2

PK: Area Under the Plasma Concentration -Time Curve of Galunisertib From Time Zero to 24 Hours (AUC [0-24h]) at Steady State

All participants who received at least one dose of study drug and were evaluable for TE ADA.

Number of Participants With Anti-Nivolumab Antibodies When Administered in Combination With Galunisertib

All participants who received at least one dose of study drug in the Phase 2 cohorts. Censored participants Galunisertib + Nivolumab (NSCLC) Phase 2 = 6.

Phase 2: Progression Free Survival (PFS)

All participants who received at least one dose of study drug in Phase 2 cohorts.

Phase 2: Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response or Partial Response: Objective Response Rate (ORR)

150 mg Galunisertib administered orally BID for the first 14 days of each 4-week cycle in combination with 3 mg/kg nivolumab given IV every 2 weeks (Day 1 and Day 15) of each 4-week cycle. Participants may continue to receive study drug until discontinuation criteria are met.

All participants who received at least one dose of study drug in Phase 2 cohorts and had a response of complete response or partial response. Censored participants Galunisertib + Nivolumab (NSCLC) Phase 2 = 1.

Phase 2: Duration of Response (DoR)

All participants who received at least one dose of study drug in Phase 2 cohorts and had a documented response of CR or PR.

Phase 2: Time to Response

All participants who received at least one dose of study drug in Phase 2 cohorts. Censored participants Galunisertib + Nivolumab (NSCLC) Phase 2 = 8.

Phase 2: Overall Survival (OS)

50 milligram (mg) Galunisertib administered orally daily (QD) on Day 1 through Day 14 of each 4-week cycle in combination with 3 milligrams per kilogram (3 mg/kg) nivolumab given intravenously (IV), every 2 weeks (Q2W), on Day 1 and Day 15 for 2 cycles. Participants may continue to receive study drug until discontinuation criteria are met.

50 mg Galunisertib administered orally twice daily (BID) on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV, Q2W, on Day 1 and Day 15 for 2 cycles. Participants may continue to receive study drug until discontinuation criteria are met.

80 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV, Q2W, on Day 1 and Day 15 for 2 cycles. Participants may continue to receive study drug until discontinuation criteria are met.

150 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV, Q2W, on Day 1 and Day 15 for 2 cycles. Participants may continue to receive study drug until discontinuation criteria are met.

150 mg Galunisertib administered orally BID for the first 14 days of each 4 week cycle in combination with 3 mg/kg nivolumab given IV, Q2W, (Day 1 and Day 15) of each 4-week cycle. Participants may continue to receive study drug until discontinuation criteria are met.

Galunisertib + Nivolumab - Non-Small Cell Lung Cancer (NSCLC) Phase 2

Galunisertib + Nivolumab - Hepatocellular Carcinoma (HCC) Phase 2

Overall Study

150 milligrams galunisertib given orally twice daily (BID) for 14 days followed by 14 days with no study drug (28 day cycles). Treatment is expected to last for 6 cycles. Participants may receive additional cycles if they are deriving clinical benefit.

The main purpose of this study is to learn more about how the study drug called galunisertib affects the immune system in participants with cancer. The study treatment is expected to last about six months for each participant, not including screening or follow-up.

A Study of Galunisertib on the Immune System in Participants With Cancer

Phase 1 Study to Determine the Immunomodulatory Activity of LY2157299 Monohydrate in Patients With Solid Tumors

Gland and Hormone Related Diseases

Rare Diseases

Neoplasm Metastasis

Pancreatic Neoplasms

Neoplastic Processes

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Gemcitabine

Antimetabolites

Cohort 1: 40 mg Galunisertib was administered orally twice daily (BID) for 14 days followed by 14 days of rest (28 day cycle).

Gemcitabine at a dose of 1000 mg/m\^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks.

Cohort 2: 80 mg Galunisertib was administered orally twice daily for 14 days followed by 14 days of rest (28 day cycle).

Gemcitabine at a dose of 1000 mg/m\^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks.

Cohort 3: 150 mg Galunisertib was administered orally twice daily for 14 days followed by 14 days of rest (28 day cycle).

Gemcitabine at a dose of 1000 mg/m\^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks.

Galunisertib recommended dose (300 mg) determined from phase 1, administered orally twice daily for 14 days followed by 14 days of rest (28 day cycle).

Gemcitabine at a dose of 1000 mg/m\^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks.

Placebo administered orally twice daily for 14 days followed 14 days of rest (28 day cycle).

Gemcitabine at a dose of 1000 mg/m\^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks.

Placebo

Phase 1b: To determine the safe and tolerable dose of galunisertib in combination with gemcitabine in patients with solid malignancy

Phase 2a: To compare the overall survival (OS) of patients with Stage II to IV unresectable pancreatic cancer when treated with a combination of galunisertib and gemcitabine with that of gemcitabine plus placebo.

A Study in Metastatic Cancer and Advanced or Metastatic Unresectable Pancreatic Cancer

A Phase 1b/2 Study With Gemcitabine and LY2157299 for Patients With Metastatic Cancer (Phase 1b) and Advanced or Metastatic Unresectable Pancreatic Cancer (Phase 2)

The recommended Phase 2 dose was the highest dose where less than 1/3 of participants experienced dose limiting toxicities (DLTs). The recommended dose was determined based on a review of overall toxicity, dose reductions, omissions, and pharmacokinetic information from Phase 1b.

Overall survival is defined as the time from the date of randomization to the date of death from any cause. For each participant who is not known to have died as of the data-inclusion cut-off date for a particular analysis, overall survival duration was censored for that analysis at the date of last prior contact.

AUC\[0-24h\] is a combined measure obtained from Day 14 at 0 hour (pre-dose), 0.5, 2,3, 6 hours post dose and morning doses from 24h and 48h to compute. AUC0-infinity will take 48h and extrapolation beyond this in addition to earlier time points to be calculated. All mentioned time points are used to calculate the two AUCs.

Plasma samples for pharmacokinetic (PK) analysis were obtained on Day 14 at 0 hours (Pre-dose), 0.5, 2, 3, 6 hours post dose and morning doses from 24h and 48h. Cmax takes all time points post dose into account and one value is reported.

Response was defined using RECIST (Response Evaluation Criteria in Solid Tumors) version 1.1. Complete Response (CR) was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeter (mm) and normalization of tumor marker level of non-target lesions; Partial Response (PR) was defined as having at least a 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD) was defined as having at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase above nadir; Stable Disease (SD) was defined as small changes that did not meet above criteria.

PFS is defined as the date of randomization to the first date of progression of disease or of death from any cause. For each participant who is not known to have died or to have had a progression of disease as of the data-inclusion cut-off date for a particular analysis, PFS will be censored at the date of last prior contact. PFS will be calculated and analyzed twice: (1) including clinical progressions of disease not based on lesion measurements, and (2) excluding clinical progressions. Progression Disease (PD) was defined as having at least a 25% increase in the sum of the longest diameter of target lesions.

Change in tumor size is defined as the maximum percent change from baseline in the sum of target lesions. Change was assessed in each participant using radiographic imaging.

Overall response rate is the best response of complete response (CR) or partial response (PR) as classified by the independent central review according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with at least 1 measurable lesion, multiplied by 100.

AUC\[0-24\] is a combined measure obtained from Day 14 at 0 hour (pre-dose), 0.5, 2,3, 6 hours post dose and morning doses from 24h and 48h to compute.

The BPI-SF Pain Severity Subscale was a participant-rated questionnaire that measured the severity of pain. Severity scores could have ranged from 0 (no pain) to 10 (pain as bad as you can imagine) for questions that included assessing average pain in the past 24 hours.

Carbohydrate antigen 19-9 (CA 19-9) is a modified Lewis(a) blood group antigen, and has been used as a tumor marker. The outcome measure is the median, minimum and maximum values from participants who had samples collected at baseline and at follow-up

Phase 1b: 80 mg Galunisertib + Gemcitabine

Phase 1b: 160 mg Galunisertib + Gemcitabine

Phase 1b: 300 mg Galunisertib + Gemcitabine

Phase 2: 300 mg Galunisertib + Gemcitabine

Phase 2: Placebo + Gemcitabine

Placebo administered orally twice daily for 14 days followed 14 days of rest (28 day cycle).

Gemcitabine at a dose of 1000 mg/m\^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks. participants may continue until disease progression, unacceptable toxicity, or another withdrawal criterion is met.

Ethnicity (NIH/OMB)

Belgium

Italy

France

Germany

Participants received galunisertib at a starting dose of 80 mg/day in combination with gemcitabine. Dose escalation proceeded in cohorts of between 3 to 6 evaluable participants until ≥2 participants experienced a dose limiting toxicity (DLT) or an galunisertib dose level of 300 mg/day was reached.

Phase 1b: All participants who received at least one dose of study drug.

Phase 1b: Recommended Phase 2 Dose

Placebo administered orally twice daily for 14 days followed 14 days of rest (28 day cycle).

Gemcitabine at a dose of 1000 mg/m\^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks. Participant's may continue until disease progression, unacceptable toxicity, or another withdrawal criterion is met.

All randomized participants who received at least one dose of study drug and had baseline \& at least one post baseline observation. Number of participants censored were Galunisertib + Gemcitabine = 20 and Placebo + Gemcitabine = 4.

AUC(0-24)

AUC(0-∞)

Phase 1b: All participants who received at least one dose of study drug and had evaluable PK (pharmacokinetics) data.

Phase 1b: Pharmacokinetics: Area Under the Concentration-Time Curve at Steady State From Time Zero to 24 Hours (AUC[0-24], ss) and Time Zero to Infinity (AUC[0-∞], ss)

Phase 1b: All participants who received at least one dose of study drug and had evaluable PK data.

Phase 1b: Pharmacokinetics: Maximum Plasma Drug Concentration at Steady State (Cmax,ss)

Progressive Disease (PD)

Stable Disease (SD)

Partial Response (PR)

Non-Complete Response/Non-Progressive Disease (NC)

Not Assessed (NA)

Phase 1b: Number of Participants With Tumor Response

All randomized participants who received at least one dose of study drug and had baseline \& at least one post baseline observation. Number of participants censored were Galunisertib + Gemcitabine = 21 and Placebo + Gemcitabine = 11.

Independent Assessor 1

Independent Assessor 2

All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for change in tumor size.

Phase 2: Percentage Change From Baseline in Tumor Size (CTS)

All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for ORR.

Phase 2: Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Overall Response Rate[ORR])

All randomized participants who received at least 1 dose of study drug with evaluable PK data.

Phase 2: Population Pharmacokinetics (PK): Area Under the Concentration-Time Curve From Time Zero to 24 Hours (AUC[0-24])

Phase 2: Population PK: Maximum Concentration (Cmax) of Galunisertib

Placebo+Gemcitabine

All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for BPI-sf.

Phase 2: Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) at Study Completion

All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for CA19-9 level.

Phase 2: Change From Baseline in Carbohydrate Antigen 19.9 (CA19-9) Level at First Study Completion Follow-up

Cohort 1: 40 mg Galunisertib was administered orally twice daily (BID) for 14 days followed by 14 days of rest (28 day cycle).

Gemcitabine at a dose of 1000 mg/m\^2 (milligrams per square meter) was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of Galunisertib (LY2157299) in Combination With Nivolumab in Advanced Refractory Solid Tumors and in Recurrent or Refractory NSCLC, or Hepatocellular Carcinoma	NCT02423343	Solid Tumor Non-Small Cell ... Hepatocellular ...	Galunisertib Nivolumab	18 Years -	Eli Lilly and Company
A Study of Galunisertib on the Immune System in Participants With Cancer	NCT02304419	Neoplasm	Galunisertib	18 Years -	Eli Lilly and Company
A Study of Galunisertib (LY2157299) in Combination With Nivolumab in Advanced Refractory Solid Tumors and in Recurrent or Refractory NSCLC, or Hepatocellular Carcinoma	NCT02423343	Solid Tumor Non-Small Cell ... Hepatocellular ...	Galunisertib Nivolumab	18 Years -	Eli Lilly and Company
A Study in Metastatic Cancer and Advanced or Metastatic Unresectable Pancreatic Cancer	NCT01373164	Neoplasms Neoplasm Metast... Pancreatic Canc...	Galunisertib Gemcitabine Placebo	18 Years -	Eli Lilly and Company
A Study of Galunisertib (LY2157299) and Durvalumab (MEDI4736) in Participants With Metastatic Pancreatic Cancer	NCT02734160	Metastatic Panc...	Galunisertib Durvalumab	18 Years -	Eli Lilly and Company
Paclitaxel/Carboplatin + Galunisertib for Patients With Carcinosarcoma of the Uterus or Ovary	NCT03206177	Carcinosarcoma,...	Galunisertib Paclitaxel Carboplatin	18 Years - 99 Years	University of Oklahoma
Galunisertib and Capecitabine in Advanced Resistant TGF-beta Activated Colorectal Cancer	NCT03470350	Colorectal Canc...	Galunisertib	18 Years -	The Netherlands Cancer Institute
Galunisertib and Capecitabine in Advanced Resistant TGF-beta Activated Colorectal Cancer	NCT03470350	Colorectal Canc...	Galunisertib	18 Years -	The Netherlands Cancer Institute

Spots Global Cancer Trial Database for galunisertib

Every month we try and update this database with for galunisertib cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.